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Your breast prosthesis fitting appointment - patient information

Description: This factsheet explains what a breast prosthesis is, what a breast prosthesis fitting appointment is and what will happen at your
Url: /Media/UHS-website-2019/Patientinformation/Womenshealth/Your-breast-prosthesis-fitting-appointment-4069-PIL.pdf

Adult cancer care wig fitting service - patient information

Description: This factsheet provides information about the adult cancer care wig fitting service at University Hospital Southampton NHS Foundation Trust (UHS).
Url: /Media/UHS-website-2019/Patientinformation/Cancercare/Adult-cancer-care-wig-fitting-service-1532-PIL.pdf

Fit for surgery school - patient information

Description: This factsheet explains what the education session 'fit for surgery school' is about and provides instructions on how to join online.
Url: /Media/UHS-website-2019/Patientinformation/Surgery/Fit-for-surgery-school-3490-PIL.pdf

The Flange FITS Guide for optimal comfort, efficiency and milk yield

Description: THE FLANGE FITS™ GUIDE for optimal comfort, efficiency and milk yield a results-based method for pumping Feel Intensity Tempo Supply SIDE VIEW PARENT’S VIEW ©Copyright Babies in Common 2023 Jeanette Mesite Frem, IBCLC. Reproduction permitted with attribution. April 2023. Best Fit • only nipple pulled into tunnel • sides of nipple touch walls of tunnel • nipple moves a little bit back and forth in tunnel • milk sprays during pumping • best to pump 15-20 minutes (both sides at same time) • feels like nothing or a gentle tug Too Large Much Too Large • might hurt • might get less milk or more drips than sprays • nipple might move side to side in tunnel • pumping might take a long time • more chance for nipple swelling and damage • areola goes into tunnel and can swell • outdated recommendations will indicate this as best fit; newer clinical evidence finds this too large babiesincommon.com Feel of the flange (size, shape, material) Which flange size, shape or material is the most comfortable (but also gets out the most milk)? Often, a flange that is closest to the actual size of the nipple feels best (and gets the most milk out). Start by measuring how wide the tip of each nipple is (left can be different than right). 1. Gently touch/tug the nipple to help it stick out a bit. 2. Use a tool with centimeters (cm) or millimeters (mm). Start with 0 next to one edge of the nipple tip. The tool does not need to touch the nipple. 3. Turn on the pump on a low vacuum/intensity level and try pumping with 2 or 3 hard plastic flange sizes: one a little smaller than the nipple, one about the same size, and one a little bigger than the nipple. • Best fit or optimal fit: The sides of the nipple touch the sides of the flange tunnel and the nipple gently glides a little bit back and forth. It should also be comfortable and milk should come out easily. • Too small: The nipple will not move easily in the tunnel and less/no milk comes out. • Too large: It may hurt, make the nipple get bigger than it usually is (swollen) and less milk comes out. A thin layer of coconut oil or nipple balm on the bend of the flange can increase comfort. Pumping should feel good and get plenty of milk out! Intensity of the pump (vacuum pressure/pull) How strongly does the pump pull on the nipple? The intensity of the pull of the nipple into the flange tunnel depends on the pump. Not all pumps are the same. Not all pumping parents need a strong pull when pumping. Once milk starts spraying and there is complete comfort, stay on that vacuum level and play with the pump cycle speed. Increase the intensity of the pull during the pumping session if it is comfortable and you see more milk sprays. Pumping should be comfortable from start to finish – it should not be something to "tolerate". Nipples should feel good when the pumping session is done. The size of the nipple (width) should be about the same as before pumping (but the nipple may be longer after pumping). Tempo of the pump (cycle speed, rhythm, vibration) What is the best tempo of the pump? The one that helps the most milk come out. The tempo is not only the speed, or cycle, but also the rhythm. Some pumps have simple tempos and others have options. Think of tempo like music for dance. Some tempos are faster, slower, or a combination of fast and slow. See what works best for your body with the pump you have. Some pumps have more of a pull-release rhythm and others have more of a vibration. Helpful Tips: • Start on the fastest tempo and after milk is coming out for 20-30 seconds, change to a slower tempo – more sprays should come out. • If sprays stop at some point during the pumping session, change the tempo back to faster for 1-2 minutes and then back to slower again. There are people who stay on a faster tempo the entire pumping session—play with the tempo to discover what works best to get the most milk out but with comfort. Some parents may need to find a different pump that works better for their body. A pumping session ideally would last 15-20 minutes. Supply of milk (drips, dribbles; strong sprays are ideal) How much milk should someone get when pumping? The answer depends on many factors but the goal is to see sprays of milk during pumping. Drips and dribbles are fine for part of a pumping session but, ideally, sprays would be seen/heard for most of the pumping session. Helpful Tips: • Many people find they get the most milk when they have the best flange fit. They may also get the same amount or more milk in a shorter amount of time when pumping than with flanges that are too large. • Hands-on pumping during pumping and hand expression of milk after pumping can help get more milk out. • The left breast may make more or less milk than the right • It's normal to get more milk in the morning hours. If you want to make more milk overall, it's best to seek out help from a lactation professional who specializes in pumping and milk supply. What about silicone flanges and inserts? For parents who wish to get more milk during pump sessions but who want to try silicone inserts or silicone flanges, it is best to try hard plastic flanges first to find the ideal size for each nipple. Then try silicone flanges and/or inserts and see how the comfort and amount of milk pumped compares to using the best fitting hard flange. Many people find that they get more milk with a hard flange that is the optimal size, and they are completely comfortable. Need help? Find a lactation professional who has experience observing pumping sessions with varied flange options. They can do an in-person or video meeting to help find the optimal flange size for you. If you have questions or want help finding someone near you who can help with flange fitting, email jeanette@babiesincommon.com. The Flange FITS™ Guide by Jeanette Mesite Frem MHS, IBCLC, RLC, CCE. Reproduction and distribution permitted with attribution. No editing or cropping permitted. Editing Assistance: Nikki Lee, RN, BSN, MS, IBCLC, RLC, CCE & the Washington State Dept of Health WIC Program. Stephanie Audette Connor, graphic designer. areola nipple tip Measure nipple tip before pumping to estimate which flange sizes to try. 1cm = 10mm. Flange sizes are in mm. page 2/2 | v.2, 4/2023
Url: /Media/UHS-website-2019/Docs/Services/Maternity/The-Flange-FITS-Guide-for-optimal-comfort-efficiency-and-milk-yield.pdf

Hearing aid fitting booklet

Description: Fitting your child’s hearing aids Name: Hearing aid: Audiology Services Battery: 312 13 675 brown orange blue RT LT Parts
Url: /Media/UHS-website-2019/Docs/Services/Child-health/Childrens-hearing/Hearing-aid-fitting-booklet.pdf

How to collect your FIT sample

Url: /Media/UHS-website-2019/Videos/Services/How-to-collect-your-FIT-sample.mp4

Papers Trust Board - 11 November 2025

Description: Date Time Location Chair Agenda Trust Board – Open Session 11/11/2025 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story (item deferred) The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 9 September 2025 Approve the minutes of the previous meeting held on 9 September 2025 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Audit and Risk Committee 9:05 Keith Evans, Chair 5.2 Briefing from the Chair of the Finance, Investment & Cash Committee 9:10 David Liverseidge, Chair 5.3 Briefing from the Chair of the People and Organisational Development 9:15 Committee Jane Harwood, Chair 5.4 Briefing from the Chair of the Quality Committee 9:20 Tim Peachey, Chair 5.5 Chief Executive Officer's Report 9:25 Receive and note the report Sponsor: David French, Chief Executive Officer 5.6 Performance KPI Report for Month 6 10:00 Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer 5.7 Break 10:40 5.8 Finance Report for Month 6 10:55 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 ICB System Report for Month 6 11:05 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.10 11:10 People Report for Month 6 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.11 NHSE Audit and review of 'Developing Workforce Safeguards' including 11:20 UHS Self-Assessment Return Review and approve the self-assessment return Sponsor: Natasha Watts, Acting Chief Nursing Officer 5.12 11:30 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan Review and discuss the report and update Sponsor: Paul Grundy, Chief Medical Officer Attendee: Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant 5.13 Annual Clinical Outcomes Summary Report 11:45 Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendees: Lucinda Hood, Head of Medical Directorate/Kate Pryde, Clinical Director for Improvement and Clinical Effectiveness 6 STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 2 Review 11:55 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendee: Martin de Sousa, Director of Strategy and Partnerships 6.2 Board Assurance Framework (BAF) Update 12:05 Review and discuss the update Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager Page 2 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors' (CoG) meeting 28 October 2025 12:15 (Oral) Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 Register of Seals and Chair's Actions Report 12:25 Receive and ratify In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 7.3 Health and Safety Services Annual Report 2024-25 12:30 Receive and discuss Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Vickie Purdie, Head of Patient Safety/Scott Spencer, Health and Safety Adviser 8 Any other business 12:40 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 13 January 2026 10 Items circulated to the Board for reading 12:45 10.1 South Central Regional Research Delivery Network (SC RRDN) 2025-26 Q2 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 11 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 12 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 11 November 2025 – Open Session Overview of the BAF Risk 1a: Lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. 4a: We do not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. Agenda links to the BAF No Item Linked BAF risk(s) 5.6 Performance KPI Report for Month 6 5.8 Finance Report for Month 6 5.9 ICB System Report for Month 6 5.10 People Report for Month 6 5.11 Workforce Safeguards Self-Assessment 5.12 Guardian of Safe Working Hours Quarterly Report 5.13 Clinical Outcomes Summary Report 1a, 1b, 1c 5a 5a 3a, 3b, 3c 1a, 3a 3a, 3b 1a, 1b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x Minutes Trust Board – Open Session Date 09/09/2025 Time 9:00 – 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Diana Eccles, NED (DE) Keith Evans, Deputy Chair and NED (KE) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Andy Hyett, Chief Operating Officer (AH) David Liverseidge, NED (DL) Alison Tattersall, NED (AT) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.1) Danielle Honey, Named Nurse for Safeguarding Children (DH) (item 5.14) Lucinda Hood, Head of Medical Directorate (LH) (item 5.15) Duncan Linning-Karp, Deputy Chief Operating Officer (DL-K) (item 5.6) Corinne Miller, Named Nurse for Safeguarding Adults (CMi) (item 5.14) Jenny Milner, Associate Director of Patient Experience (JM) (items 5.11-5.12) 1 member of the public (item 2) 30 members of staff (observing) 6 members of the public (observing) Apologies Gail Byrne, Chief Nursing Officer (GB) David French, Chief Executive Officer (DAF) Tim Peachey, NED (TP) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Gail Byrne, David French and Tim Peachey. The Chair provided an overview of meetings she had held and events that she had attended since the previous Board meeting. 2. Patient Story Aelwen Emmett, a volunteer at the Trust and former patient was invited to present her experience, focusing particularly on her work to improve the standard of food offered to patients. 3. Minutes of the Previous Meeting held on 15 July 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 15 July 2025. Page 1 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. In respect of action 1246, it was noted that virtual outpatient appointments had now been built into the Trust’s programme. Furthermore, meetings were to be held with commissioners and the cancer network to improve the quality of referrals. It was noted that action 1246 could be closed. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Finance and Investment Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 21 July and 2 September 2025, the content of which was noted. It was further noted that: • In July 2025, the Trust had reported that it was £1.1m adverse to its plan, but that the underlying trajectory was improving. • The committee received an update from Wessex NHS Procurement Limited, noting that the company was on track in terms of its Cost Improvement Programme target. • The committee had received an update in respect of both the proposed Hampshire and Isle of Wight elective hub and a possible Urgent Treatment Centre at Southampton. • The committee reviewed the Finance Report for Month 4 (item 5.8), noting that the Trust had reported a year-to-date deficit of £19.5m, which was £5.8m adverse to plan. Key drivers for the Trust’s financial position included the lack of improvement in the number of patients having no criteria to reside and mental health patients, the continued difference between funded and actual activity under block contracts, lower than anticipated income, and higher than planned workforce numbers. • The Trust was ahead of its plan on Cost Improvement Programme delivery. • The committee reviewed the Trust’s proposed Financial Recovery Plan and noted the need to ensure that the long-term impact of decisions needed to be taken into account. • The committee reviewed the Trust’s cash position and noted that cash support would be required in the Autumn and that the committee would be amending its terms of reference to expand its role in terms of cash monitoring and oversight. • The committee reviewed the Board Assurance Framework risks within its remit, noting that Risk 5a had increased to 25 due to the risk associated with the Trust’s cash position (item 6.1). 5.2 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Reports in respect of the meetings held on 21 July and 1 September 2025, the content of which was noted. It was further noted that: • The committee reviewed the People Report for Month 4 (item 5.10), noting that there continued to be significant demands on the Trust’s workforce, especially due to the number of patients having no criteria to reside and patients with a primary mental health need. Whilst the Trust’s substantive workforce had reduced, there had been an increase in the number of temporary staff resulting in the Trust reporting that it was 55 whole-time- equivalents above its plan. Page 2 • The committee considered the impact of the recruitment controls on the administrative and clerical workforce and the potential for shortages in these areas causing issues elsewhere. • The committee received an update in respect of the Mutually Agreed Resignation Scheme (MARS), noting that 65 applications had been approved. • The committee received an update on the recruitment of newly qualified nurses, noting that the Trust had pre-empted the announcement of a ‘guarantee’ by the Secretary of State. • The committee reviewed the workforce related elements of the Trust’s Financial Recovery Plan, noting the challenges in delivering what was required and the Trust’s reliance on improvements in patients having no criteria to reside and mental health patients. • The committee reviewed its terms of reference, proposing to make only minor changes (item 7.2). 5.3 Briefing from the Chair of the Quality Committee Diana Eccles was invited to present the Committee Chair’s Report in respect of the meeting held on 18 August 2025, the content of which was noted. It was further noted that: • The committee considered the proposal to revise enhanced rates paid to temporary staff in certain areas to remove the enhancement and bring rates into line with Agenda for Change rates. The committee noted the impact on staff and the concerns expressed by staff members. However, it was further noted that the enhancements were not intended to be permanent. • The committee received the Experience of Care report and noted a continuation in the trend observed during Quarter 4 of staff attitudes featuring as a reason for complaint. It was considered likely that this was indicative of the pressures on staff. • The committee reviewed the Maternity and Neonatal Safety 2025-26 Quarter 1 Report, noting that an action plan was in place in respect of the Maternity Triage Line to address some shortcomings identified in the process. • The committee received the Learning from Deaths 2025-26 Quarter 1 Report (item 5.11), noting that the Trust was one of only 11 trusts out of 119 with a lower-than-expected death rate during the period. • The committee reviewed the Safeguarding Annual Report 2024-25 and Strategy 2025-26 (item 5.14), noting that activity levels remained consistent with prior years, but the complexity of cases had increased. 5.4 Chief Executive Officer’s Report Paul Grundy was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • The NHS league tables for 2025 had been published on 9 September 2025. The Trust had ranked 48th out of 134 and had been placed in segment 3 of the NHS Oversight Framework due to the effect of the ‘financial override’. The Trust was temporarily in segment 5 due to being in the Recovery Support Programme. • Trusts were required to submit self-assessments for the Provider Capability Assessment during October 2025. This would inform decisions relating to which organisations to place in the Performance Improvement Programme. • Resident doctors undertook strike action between 25 and 30 July 2025. Approximately one-third of those eligible at the Trust took part in the industrial action and the Trust had performed well in terms of mitigating the impact on activity. Page 3 • The Royal College of Nursing had published results of its analysis of violence and aggression against nursing staff in emergency departments, noting that the number of incidents had increased from 2,093 in 2019 to 4,054 in 2024. • NHS England had published a series of urgent and emergency care improvement guides to assist organisations with managing the winter period. • A number of changes to the organisation of local councils in Hampshire and Southampton were proposed as part of national plans to create unitary councils in place of existing county and district/borough councils. 5.5 Performance KPI Report for Month 4 Andy Hyett was invited to present the Performance KPI Report for Month 4, the content of which was noted. It was further noted that: • The Trust had reported an increase in the number of patients waiting over 52, 65 and 78 weeks alongside an increase in the overall waiting list. The Trust had entered Tier 2 escalation for Referral To Treatment performance. • The Trust had been placed in Tier 1 escalation due to the gap between its current Emergency Department performance and its performance plan for 2025/26. However, indicative data for August and September 2025 showed improved performance. • Work was ongoing to improve flow with task and finish groups established to review the discharge process and to implement rapid improvements. • The number of patients having no criteria to reside and those with a primary mental health need remained high. A workshop had been set up with Hampshire and Isle of Wight Healthcare NHS Foundation Trust in respect of mental health patients. • Steps were being undertaken to reduce the number of inappropriate attendances in the Emergency Department with patients potentially redirected to other areas. However, an Urgent Treatment Centre would be key to alleviating pressure on the Emergency Department in the longer term. The Board discussed the Trust’s performance against national standards. This discussion is summarised below: • Performance against the 62-day standard for cancer waiting times was an area of focus to ensure more consistent performance. • Work was ongoing to extend shared decision-making in order to involve patients in decisions about their care and treatment, noting however that this was more of a challenge with inpatients. • There was a challenge in terms of managing the demand for patients requiring diagnostic services. It was noted that there had been issues with availability of equipment over the summer period. It was acknowledged that diagnostics performance also impacted other areas such as cancer and Emergency Department metrics. • The percentage of over 65s attending the Emergency Department was expected to be a key metric to monitor over the winter period. Actions Andy Hyett agreed to look at the roll out of Pharmacy First. Andy Hyett agreed to carry out a deep-dive into Diagnostics to be either provided as a ‘Spotlight’ in the Performance KPI Report or via a Trust Board Study Session. Page 4 5.6 UHS Operating Plan 2025-26 and Board Assurance Statement Andy Hyett was invited to present the Operating Plan 2025-26 and Board Assurance Statement, the content of which was noted. It was further noted that: • The Operating Plan provided a summary of plans from October 2025 to September 2026, sitting alongside other key policies such as those relating to infection prevention control, major incidents, and influenza. • The Operating Plan would also serve as the Trust’s winter plan, which was recognised as a period of increased pressure. The Board discussed the proposed Operating Plan for 2025/26, this discussion is summarised below: • It was considered likely that, even with delivery of the demand management schemes being led by the Integrated Care Board (ICB), there would be a gap between demand and capacity over the winter period in particular. Therefore, further interventions to improve discharge rates and to reduce the number of patients having no criteria to reside would be necessary. In addition, the Trust would be required to make potentially difficult decisions in respect of prioritisation of patients and possible cancellation of elective procedures. • Concerns were expressed in relation to the trend of low uptakes of seasonal vaccinations, such as that against influenza, which had been seen since the COVID-19 pandemic. This situation would likely create further challenges due to patients with seasonal illnesses requiring additional infection prevention control measures. Furthermore, low uptake by staff members would likely result in increased rates of staff sickness and, accordingly, reduced capacity and/or increased expenditure on temporary staffing. • It was understood that there was a NHS campaign to encourage staff in particular to be vaccinated against influenza, and that plans were in place for senior leaders to visibly support this campaign through being vaccinated. • The Board challenged whether the Trust could meet the targets set out in the Operating Plan given the financial and other pressures currently experienced. • It was additionally noted that the Trust was reliant on external support and delivery of external demand management programmes led by the ICB in order to be able to meet the performance targets, especially in terms of management of the number of patients having no criteria to reside and those with a primary mental health need. • Furthermore, the Trust’s financial position was such that it was required to produce a financial recovery plan, which would require additional financial savings to be made. • It was agreed that the Board should fully consider whether to approve the Operating Plan once it had considered the Trust’s financial recovery plan in the Closed Session of the meeting. [Note: the matters below forming part of item 5.6 were discussed following the approval of the Trust’s financial recovery plan in the Closed Session.] Noting that the Board had discussed and supported the Trust’s financial recovery plan, subject to certain caveats, the Board again discussed the proposed Operating Plan for 2025/26. This discussion is summarised below: • The Trust’s financial recovery plan would need to be supported by NHS England and would also need to deliver in order for the Trust to be able to meet the performance targets set out in the Operating Plan. • The Trust continued to have significant dependence on third parties, especially other providers, the Integrated Care Board, and local authorities, to be able to successfully reduce the number of patients having no criteria to Page 5 reside or number of mental health patients. Without these reductions, the Trust would face significant capacity constraints, which would impact its performance, especially during periods of high demand. Decision Noting the discussions in the Closed Session in respect of the financial recovery plan, and having reviewed the proposed Operating Plan 2025-26 and accompanying Board Assurance Statement, the Board approved the Operating Plan 2025-26 and its submission, subject to the following: • delivery of system-wide programmes to manage demand and reduce numbers of non-criteria to reside and mental health patients, • appropriate support being provided by third parties, including local providers, the Integrated Care Board, and local authorities, especially in terms of supporting discharges and managing numbers of non-criteria to reside and mental health patients, and • support from NHS England for and delivery of the Trust’s financial recovery plan. In addition, the Board authorised the Chair and Chief Executive Officer to sign the Board Assurance Statement. 5.7 Break 5.8 Finance Report for Month 4 Ian Howard was invited to present the Finance Report for Month 4, the content of which was noted. It was further noted that: • The Trust had reported an in-month deficit of £6.8m (£4.8m above plan), although the underlying deficit was showing improvement, reducing to £6.6m. However, this trajectory was not sufficient to deliver the plan. • The Trust was carrying out approximately £2.5m of unfunded activity per month. In order to tackle some of this amount, the Trust had conducted negotiations with other providers and systems to address underfunding on contracts. • There were concerns about whether the Trust’s elective over-performance during the first half of the year would be fully funded. Whilst agreement had been reached in respect of funding three months of over-performance, it was not clear whether this would be replicated in the future. • The Trust would be seeking an activity management plan, which would detail which activities to cease to perform on the basis that the Trust continuing to over-perform against agreed funded activity levels was financially unsustainable and that it was not reasonable that the Trust should be criticised for falling performance in areas such as waiting lists as it sought to manage its finances. • The Trust’s cash position remained an area of concern with cash support to be requested from NHS England. • There appeared to be an emerging risk of slippage against the Trust’s capital programme, which was to be discussed at the Finance and Investment Committee. 5.9 ICS Operational Delivery Report for Month 4 Ian Howard was invited to present the ICS Operational Delivery Report for Month 4, the content of which was noted. It was further noted that: • The Trust was the only organisation within the system currently reporting being off plan. However, there were indicators from other providers with Page 6 significant risks being highlighted about organisations’ abilities to meet their 2025/26 plans. • There was an error in the report in respect of the Trust’s workforce numbers. A correction to the report had been requested. • The Hampshire and Isle of Wight ICS plan was for a breakeven position at the end of 2025/26. However, this was reliant on receipt of £60m of deficit support funding from NHS England, which was at risk because the Trust was no longer reporting being on plan. 5.10 People Report for Month 4 It was noted that two questions had been received from members of the public prior to the meeting (see Annex A), both of which related to the decision to remove the enhancement from NHS Professionals rates paid to staff in certain areas of the Trust such as in Theatres and in the Emergency Department. It was further noted that: • A discussion had also been held with staff prior to the Board meeting, at which a number of other questions had been raised. In particular, staff had expressed concerns about their feeling valued by the organisation. • The reasoning behind the decision to remove the enhancement previously paid on temporary staffing rates was explained as being to provide consistency with other staffing groups and with other providers by aligning rates paid with Agenda for Change rates. This change was part of a package of measures to improve the financial position of the Trust. • The decision to remove the enhancement was supported by an Equality and Quality Impact Assessment as part of the Trust’s process for making decisions of this nature. [Post meeting note: Following the meeting, the Royal College of Nursing, on behalf of its members in the affected areas, submitted a collective dispute. The questions raised in advance of the meeting, together with other related points, were to be addressed as part of the collective dispute process.] Steve Harris was invited to present the People Report for Month 4, the content of which was noted. It was further noted that: • The Trust’s plan for 2025/26 was for a reduction in whole-time-equivalents (WTE) by 765. Whilst the Trust had reduced the size of its workforce, it was still 55 WTE off-plan. • The Trust had reduced the number of divisions from four to three and had implemented recruitment controls whereby only 70% of clinical posts would be recruited to and a prohibition on recruitment to non-clinical posts. • The Trust had also carried out a Mutually Agreed Resignation Scheme (MARS) and had made some redundancies in discrete areas. It was noted, however, that there was a lack of funding for severance payments, which limited the Trust’s options with respect to steps it could take to reduce its workforce. • Temporary staffing was a particular area of focus, both in terms of numbers of temporary staff but also in terms of the cost paid for such staff. This aligned with the work of the South East temporary staffing collaborative which aimed to reduce the price of temporary labour in both bank and agency. Page 7 • Despite its challenges during 2025/26, the Trust had proactively offered roles to newly-qualified nurses ahead of the Secretary of State’s announcement of a ‘graduate guarantee’ on the basis that, from a strategic perspective, the Trust needed to take into account its future workforce requirements. Action Steve Harris and Andy Hyett agreed to respond to the questions and points raised at the meeting held with staff in respect of the NHS Professionals rates matter. 5.11 Learning from Deaths 2025-26 Quarter 1 Report Jenny Milner was invited to present the Learning from Deaths 2025/26 Quarter 1 Report, the content of which was noted. It was further noted that: • The Trust’s summary hospital-level mortality indicator (SHMI) score continued its downward trajectory and was the lowest value recorded since 2018. As such, the Trust was one of only 11 trusts nationally to achieve a lower-thanexpected mortality rate. • Work was ongoing to disseminate lessons from end-of-life care and an additional module for the Ulysses system had been purchased to facilitate data capture and standardisation for Morbidity and Mortality meetings. Action Jenny Milner was to provide further information to the Board in respect of why the Trust’s SHMI score remained low. 5.12 Annual Complaints Report 2024-25 Jenny Milner was invited to present the Annual Complaints Report 2024/25, the content of which was noted. It was further noted that: • The report provided details of complaints received between 1 April 2024 and 31 March 2025 and was the first full year of reporting against the new standard introduced by the Parliamentary and Health Service Ombudsman (PHSO). • Complaints activity had increased by 40% and the Trust was not currently meeting response targets. • The Trust benchmarked higher than others in terms of complaints not upheld. The Board discussed the Trust’s approach to complaints handling and, in particular, whether the Trust was an outlier in terms of the number of complaints not upheld. The Board challenged whether complaints deemed as ‘not upheld’ ought, in some instances, to be considered ‘partially upheld’. Consideration should therefore be given to reviewing the Trust’s complaints against PHSO referrals and outcomes. Action Jenny Milner was to provide further information regarding how the Trust was planning to meet complaints response times. Page 8 5.13 Medical Appraisal and Revalidation Annual Report including Board Statement of Compliance Paul Grundy was invited to present the Medical Appraisal and Revalidation Annual Report, the content of which was noted. It was further noted that: • The framework published by NHS England was designed to allow the Trust to provide assurance that its professional standards processes meet the relevant statutory requirements and support quality improvement. • Feedback in respect of the appraisals process had been largely positive. • Appraisal compliance rates had continued to rise across the year with a current average of 88.8%. • The Board was required to approve a Statement of Compliance confirming that the Trust was compliant with the Medical Profession (Responsible Officers) Regulations 2010 (as amended). Decision Having considered the Medical Appraisal and Revalidation Annual Report tabled to the meeting, the Board authorised the Chair or Chief Executive Officer to sign the Statement of Compliance. 5.14 Safeguarding Annual Report 2024-25 and Strategy 2025-26 Danielle Honey was invited to present the Safeguarding Annual Report 2024/25 and Strategy for 2025/26, the content of which was noted. It was further noted that: • The report summarised the activity of the Trust’s safeguarding service in 2024/25. It was noted that the service had contributed to reviews of 56 patients where a statutory review had been considered. • The number of referrals under section 42 of the Care Act 2014 caused by Southampton City Council had reduced following the implementation of the council’s new processes. This was not reflective of a reduction in the number of UHS referrals or the complexity of the referrals responded to. • There had been an increase in the number of open cases with Southampton City Council and there had been a 13% increase in the number of patients subject to Deprivation of Liberty Safeguards (DoLS) under the Mental Capacity Act 2005. • There had also been an increase in the number of scoping reviews compared to prior years, although fewer were progressing to formal reviews. • Following a survey of staff, work was underway to improve the visibility of the team and there was a focus on team wellbeing with support from the psychology team. • The situation in respect of expected changes in the role of integrated care boards was being monitored due to the potential for changes in the team’s scope and remit. Page 9 6. STRATEGY and BUSINESS PLANNING 6.1 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework update, the content of which was noted. It was further noted that: • All risks had been reviewed by the relevant executive directors since July 2025. • The revised risk appetites agreed by the Board in July 2025 were being embedded. • The rating of Risk 5a had increased from 20 to 25 due to the lack of agreement for cash support. However, once this agreement had been obtained and the Financial Recovery Plan was in place, it was expected that this risk would again reduce to 20. • An audit of the Trust’s risk management maturity by the Trust’s internal auditors was near to completion. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (COG) Meeting 16 July 2025 The Chair presented a summary of the Council of Governors’ meeting held on 16 July 2025. It was noted that the meeting had considered the following matters: • Chief Executive Officer’s Performance Report • The Trust’s 2025/26 Operating Plan • Council of Governors’ Terms of Reference • Membership Engagement • Feedback from the Governors’ Nomination Committee Furthermore, the Council of Governors approved the extension of the appointment of Tim Peachey as a non-executive director for a period of 12 months. 7.2 People and Organisational Development Committee Terms of Reference Craig Machell was invited to present the proposed changes to the People and Organisational Development Committee’s Terms of Reference, the content of which was noted. It was further noted that: • The People and Organisational Development Committee had reviewed its terms of reference at its meeting on 1 September 2025. • It was proposed to make only minor changes to remove reference to the Charitable Funds Committee, which no longer existed. Decision Having considered the proposed amendments to the People and Organisational Development Committee’s Terms of Reference, the Board approved the changes. Page 10 8. Any other business It was noted that it was organ donation week during 22-28 September 2025. Action Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. 9. Note the date of the next meeting: 11 November 2025 10. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. 11. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 11 Annex A Questions: 1. The Board has agreed a cut in bank pay rates for nursing staff, resulting in local staff being unlikely to maintain their bank roles in this organisation, (based on a survey of over 450 nurses within the affected areas). Currently these roles provide staffing in areas such as theatres and other specialised areas, the impact being these departments can use local skills and knowledge to provide seamless operational delivery. How can the board provide assurance that, a) this will not impact on safety for patients, and b) they truly value nurses for the professional skills they provide for this Trust. 2. Our Emergency Department has recently been placed under Tier 1 monitoring by NHS England, reflecting serious national concerns about safety and performance. The department is already regularly understaffed, with patient care frequently delayed as a result. In light of this, how can the Trust justify reducing NHSP pay rates for Emergency Department nurses — a decision that risks deterring skilled staff from covering shifts and further compromising patient safety and the delivery of safe, timely care? What specific steps will the Trust take to mitigate these risks to patients and staff if the changes go ahead? Page 12 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine Watts, Natasha 13/01/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Trust Board – Open Session 09/09/2025 - 5.5 Performance KPI Report for Month 4 1281. Pharmacy First Hyett, Andy 11/11/2025 Pending Explanation action item Andy Hyett agreed to look at the roll out of Pharmacy First. 1282. Diagnostics Hyett, Andy 11/11/2025 Pending Explanation action item Andy Hyett agreed to carry out a deep-dive into Diagnostics to be either provided as a ‘Spotlight’ in the Performance KPI Report or via a Trust Board Study Session. Trust Board – Open Session 09/09/2025 - 5.10 People Report for Month 4 1283. NHS Professionals rates Harris, Steve Hyett, Andy 11/11/2025 Pending Explanation action item Steve Harris and Andy Hyett agreed to respond to the questions and points raised at the meeting held with staff in respect of the NHS Professionals rates matter. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 09/09/2025 - 5.11 Learning from Deaths 2025-26 Quarter 1 Report 1284. SHMI score Milner, Jenny Watts, Natasha 11/11/2025 Pending Explanation action item Jenny Milner was to provide further information to the Board in respect of why the Trust’s SHMI score remained low. Trust Board – Open Session 09/09/2025 - 5.12 Annual Complaints Report 2024-25 1285. Response times Milner, Jenny Watts, Natasha 11/11/2025 Pending Explanation action item Jenny Milner was to provide further information regarding how the Trust was planning to meet complaints response times. Trust Board – Open Session 09/09/2025 - 8 Any other business 1286. Organ donation Machell, Craig 18/12/2025 Pending Explanation action item Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. Update: To be scheduled 18/12/25 or 03/02/26. Page 2 of 2 Agenda Item 5.1 Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Audit & Risk Committee Meeting Date: 13 October 2025 Key Messages: • • • • • • • • • The committee reviewed and discussed the outputs of a ‘lessons learned’ activity following the late publication of the Trust’s annual report and accounts. It was noted that a number of actions had been agreed and that a trial run would be conducted at Month 9. The committee noted the proposal to tender for new valuers for 2025/26 and the review of the Modern Equivalent Asset estimation methodology that would be carried out during the year. The committee agreed with a proposal to write off historical debt from private (mostly overseas) patients on the basis that it was irrecoverable. There had been 68 waivers of competitive tendering during the first half of 2025/26, most of which related to continued service provision. It was noted that the submission as part of the National Cost Collection exercise had been completed in July 2025 and that the Trust was 7% more efficient than the average based on the data. An update was received in respect of Information Governance. The Trust’s Data Security and Protection Toolkit was now rated as ‘approaching standards’ and progress had been made in respect of the backlog in subject access requests. The committee received an update in respect of legal expenditure and claims during 2024/25. The committee reviewed the internal audit reports on the Data Security and Protection Toolkit, CQC Readiness, and risk maturity. The committee received an update on the progress of the Trust’s local counter-fraud team against the plan for 2025/26, noting that imposter fraud was an area of focus. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 6.2 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • The committee had last reviewed the BAF in March 2025, and there had been a definite increase in the level of risk with the ratings of four of the risks having increased since then. • Approximately 25% of the risks on the Trust’s operational risk register were rated ‘critical’ (i.e. 15 or above). • The internal audit of risk management had been positive and the Trust’s risk management framework was considered as being mature. Any Other N/A Matters: Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Finance and Investment Committee Meeting Date: 22 September 2025 Key Messages: • • • • • • • • • The committee reviewed the Finance Report for Month 5. The Trust had reported an in-month deficit of £5.9m and £25.4m deficit year-todate. The in-month deficit was £4.2m above the original plan, but was in line with the trajectory in the Financial Recovery Plan. The Trust’s underlying deficit had continued to improve, reducing to £6.2m, although this improvement was not yet at the pace required. The main drivers of the variance to plan were variances in income compared with what had been expected during 2025/26 and variances in terms of pay costs. The Trust was expecting to be 95 whole-timeequivalents above plan at year end based on current assumptions. It was noted that the Trust had identified 100% of Cost Improvement Programme savings at Month 5 and 76% of schemes were fully developed. Approximately £37m of savings had been delivered between Months 1 and 5, although higher than anticipated levels of non-recurrent savings had been delivered. The committee reviewed the Trust’s capital forecast, noting that there was a risk of a shortfall against the Trust’s internal CDEL. An update was received regarding the Urgent and Emergency Care transformation programme. The committee received the annual assurance report from UHS Pharmacy Limited, noting the company’s performance during the year and the work being done to expand services internally and externally. The committee considered the Trust’s cash forecast for Month 5, noting that the Trust’s underlying deficit was steadily eroding the Trust’s cash balance. The Trust had introduced strict treasury management measures and had previously received advance payments from the ICB as a means to mitigate the cash position. However, it had been necessary to submit a request for revenue support from NHS England in September 2025 and further such applications would be required from November 2025 onwards. In order to increase the focus on and governance of cash-related matters, the committee reviewed its terms of reference to strengthen the cash-related provisions and agreed to recommend to the Board that the committee be re-constituted as the Finance, Investment and Cash Committee with an Operating Cash Group reporting into the committee. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) N/A Any Other Matters: The revised terms of reference for the committee were reviewed and approved at the Board meeting held on 7 October 2025. Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Finance, Investment and Cash Committee Meeting Date: 3 November 2025 Key Messages: • • • • • • • • The committee reviewed the Finance Report for Month 6 (see below). The committee received an update in respect of the Trust’s performance against its Financial Recovery Plan, noting that progress had been made in terms of putting plans in place regarding patients with no criteria to reside and mental health patients. Good progress had also been made in respect of the ‘grip and control’ measures. At Month 6, the Trust remained on track with the Financial Recovery Plan. An overview of the recently published Medium Term Planning framework was provided. It was noted that the first submission of the Trust’s three-year plan was due before
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ACCORD-2 master protocol

Description: CONFIDENTIAL ACCORD-2-001 – Master Protocol TITLE PAGE Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Master Protocol Number: ACCORD-2-001 Product: Multiple candidate agents Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): IRAS Number: RHM Number: EudraCT 2020-001736-95 282769 Date of Protocol: 22 April 2020 Version: Final Final, 22 April 2020 1 CONFIDENTIAL Chief Investigator Signatory: ACCORD-2-001 – Master Protocol I have read this protocol in its entirety and agree to conduct the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-001 – Master Protocol TABLE OF CONTENTS TABLE OF TABLES...............................................................................................................6 TABLE OF FIGURES.............................................................................................................7 1.0 PROTOCOL SUMMARY ..........................................................................................8 1.1 Synopsis.............................................................................................................8 1.2 Schema ............................................................................................................13 1.3 Example Schedule of Activities.....................................................................14 2.0 INTRODUCTION......................................................................................................18 2.1 Study Rationale ..............................................................................................18 2.2 Background ....................................................................................................18 2.3 Benefit/Risk Assessment ................................................................................19 3.0 OBJECTIVES AND ENDPOINTS ..........................................................................20 4.0 STUDY DESIGN........................................................................................................22 4.1 Overall Design ................................................................................................22 4.2 Scientific Rationale for Study Design...........................................................24 4.3 Justification for Dose .....................................................................................24 4.4 End of Study Definition .................................................................................24 5.0 STUDY POPULATION ............................................................................................25 5.1 Inclusion Criteria ...........................................................................................25 5.2 Exclusion Criteria ..........................................................................................25 5.3 Lifestyle Considerations ................................................................................26 5.4 Screen Failures ...............................................................................................26 6.0 STUDY TREATMENT .............................................................................................27 6.1 Study Treatment(s) Administered................................................................27 6.2 Preparation/Handling/Storage/Accountability ...........................................27 6.3 Measures to Minimise Bias: Randomisation and Blinding ........................28 6.4 Study Treatment Compliance.......................................................................28 6.5 Concomitant Therapy....................................................................................28 6.5.1 Rescue Medicine ...............................................................................29 6.6 Dose Modification ..........................................................................................29 6.7 Treatment after the End of the Study ..........................................................29 7.0 DISCONTINUATION OF STUDY TREATMENT AND PATIENT DISCONTINUATION/WITHDRAWAL ................................................................30 7.1 Discontinuation of Study Treatment ............................................................30 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-001 – Master Protocol 7.2 Patient Discontinuation/Withdrawal from the Study.................................30 7.3 Lost to Follow-up ...........................................................................................30 8.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................32 8.1 Efficacy Assessments .....................................................................................33 8.1.1 Improvement on the 9-Point Scale ....................................................33 8.1.2 Other Efficacy Assessments ..............................................................34 8.2 Safety Assessments.........................................................................................34 8.2.1 Physical Examinations.......................................................................34 8.2.2 Vital Signs and Blood Gases .............................................................34 8.2.3 Clinical Safety Laboratory Assessments ...........................................35 8.3 Virologic Load ................................................................................................35 8.4 Adverse Events ...............................................................................................35 8.4.1 Time Period and Frequency for Collecting AE and SAE Information ........................................................................................35 8.4.2 Method of Detecting AEs and SAEs .................................................36 8.4.3 Follow-up of AEs and SAEs .............................................................36 8.4.4 Regulatory Reporting Requirements for SAEs .................................36 8.4.5 Pregnancy ..........................................................................................37 8.4.6 Adverse Events of Special Interest ....................................................37 8.4.7 Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events.........37 8.5 Treatment of Overdose..................................................................................37 8.6 Pharmacokinetics ...........................................................................................37 8.7 Pharmacodynamics........................................................................................38 8.8 Immunology....................................................................................................38 8.9 Genomics.........................................................................................................38 8.10 Serology Research (Host Response) .............................................................39 9.0 STATISTICAL CONSIDERATIONS .....................................................................39 9.1 Design Overview.............................................................................................39 9.2 Statistical Hypotheses ....................................................................................39 9.3 Sample Size Determination ...........................................................................40 9.4 Populations for Analyses ...............................................................................42 9.5 Statistical Analyses.........................................................................................42 9.5.1 Efficacy Analyses ..............................................................................43 9.5.2 Safety Analyses .................................................................................43 9.5.3 Other Analyses ..................................................................................44 9.5.4 Missing Data......................................................................................44 9.6 Interim Analyses ............................................................................................45 9.7 Review Committees........................................................................................45 9.7.1 Steering Committee (Scientific Review Committee) ........................45 9.7.2 Independent Data and Safety Monitoring Committee.......................45 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-001 – Master Protocol 10.0 REFERENCES...........................................................................................................47 11.0 APPENDICES ............................................................................................................48 Appendix 1 Abbreviations ...................................................................................49 Appendix 2 Regulatory, Ethical, and Study Oversight Considerations..........51 Protocol Compliance........................................................................................51 Regulatory and Ethical Considerations............................................................51 Financial Disclosure.........................................................................................52 Indemnity .........................................................................................................52 Informed Consent Process ...............................................................................52 Data Protection.................................................................................................53 Administrative Structure ..................................................................................54 Dissemination of Clinical Study Data..............................................................54 Data Quality Assurance ...................................................................................54 Source Documents ...........................................................................................55 Study and Study Centre Closure ......................................................................55 Publication Policy ............................................................................................56 Appendix 3 Clinical Laboratory Tests ...............................................................57 Appendix 4 Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting .....................................59 Appendix 5 Collection of Pregnancy Information ............................................63 Appendix 6 Genetics ............................................................................................65 Appendix 7 Signature of Investigator ................................................................66 Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-001 – Master Protocol Table 1 Table 2 Table 3 Table 4 Table 5 TABLE OF TABLES Study Objectives and Endpoints ......................................................................20 Sample Size for 80% and 90% Power for Time to Improvement, Discharge from Hospital, or Fit for Discharge Using Log-rank Test for a Hazard Ratio of 1.6 in Treatment Arm to Standard of Care ...................41 Analysis Sets ....................................................................................................42 Efficacy Analyses ............................................................................................43 Protocol-required Safety Laboratory Assessments..........................................58 Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-001 – Master Protocol Figure 1 TABLE OF FIGURES Study Schema...................................................................................................13 Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-001 – Master Protocol 1.0 PROTOCOL SUMMARY 1.1 Synopsis Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Rationale: There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. Objectives and Endpoints Objectives Primary • Stage 1: To evaluate the efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. • Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID-19 in an expansion stage. Endpoints • Time to clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses). 9-point category ordinal scale: 0. Uninfected, no clinical or virological evidence of infection 1. Ambulatory, no limitation of activities 2. Ambulatory, limitation of activities 3. Hospitalised – mild disease, no oxygen therapy 4. Hospitalised – mild disease, oxygen by mask or nasal prongs 5. Hospitalised – severe disease, noninvasive ventilation or high-flow oxygen 6. Hospitalised – severe disease, intubation and mechanical ventilation 7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. Death Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-001 – Master Protocol Secondary • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • To evaluate the number of oxygen-free days. • Duration (days) of oxygen use and oxygen-free days. • To evaluate ventilator-free days and incidence and • Duration (days) of ventilation and ventilation-free duration of any form of new ventilation use. days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • To evaluate response rate (see primary endpoint for definition of responder). • Response rate (number and %) by treatment arm at Days 2, 8, 15, 22, and 29. • To evaluate time to discharge. • Time to live discharge from the hospital. • To evaluate overall mortality. • Mortality at Days 15, 29, and 60. • Time from treatment start date to death. • Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2), • SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death • To evaluate the safety of candidate agents as • Physical examination. add-on therapy to SoC in patients with COVID-19. • Clinical laboratory examinations. • Vital signs (blood pressure/heart rate/temperature/respiratory rate). • Adverse events. • To evaluate intensive care unit (ICU) and hospitalisation length. • Duration (days) of ICU and hospitalisation. • To evaluate National Early Warning Score 2 (NEWS2). • NEWS2 assessed daily while hospitalised and on Days 15 and 29. • Time to a NEWS2 of ≤2, maintained for at least 24 hours. Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-001 – Master Protocol Exploratory • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). • To collect samples for translational research on • Analysis of samples collected at baseline prior to host and viral genomics, serum antibody treatment and at specific time points. production, COVID-19 diagnostics, and validation of laboratory testing methods. Overall Design: ACCORD-2 is a seamless, Phase 2, adaptive, randomisation platform study, designed to rapidly test candidate agents in the treatment of COVID-19 disease. The study will include hospitalised adult patients (≥18 years) who have infection with SARS-CoV-2, the virus that causes COVID-19, as confirmed by laboratory tests and/or point of care tests. For inclusion, patients will need to have clinical status of Grade 3 (hospitalised – mild disease, no oxygen therapy) to Grade 5 (hospitalised – severe disease, noninvasive ventilation or high-flow oxygen), as defined by a 9-point ordinal scale. This study will aim to identify efficacious candidate agents for treatment of COVID-19 disease. These candidate agents may include, but will not be limited to, anti-virals, human plasma-derived agents, or immunomodulatory agents. Experimental (first-in-human) agents will not be considered as candidate agents for ACCORD-2, but will instead be considered for inclusion in the separate, but linked, ACCORD-1 Phase 1/2 platform study, which will first determine the dose and assess early activity and safety signals for later consideration for inclusion into ACCORD-2. The ACCORD-2 candidate agents evaluated will include those intended as a treatment for SARS-CoV-2 infection; the study design and/or inclusion and exclusion criteria may subsequently be revised (using a protocol amendment) or a separate protocol may be initiated to include agents intended to prevent COVID-19 disease. This Master Protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The Master Protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously. The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation, with the control group for a candidate agent including only patients randomised during the period in which the candidate agent group was randomised, with patients being randomised equally (ie, 1:1:1…) to the sub-protocols with inclusion/exclusion criteria that they meet. Sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. The sub-protocols may define adverse events of special interest (AESIs), and can include pharmacokinetic and/or pharmacodynamic assessments that are appropriate for the specific candidate agent (pharmacodynamic assessments may require equivalent blood samples from controls). The study consists of 2 stages: • Stage 1 of the study (evaluation/pilot) will evaluate the candidate agents as an add-on to the standard of care (SoC) to assess preliminary safety and efficacy. A patient will be considered to be a responder if they show an improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, are discharged from hospital, or are considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29. The time to response will be analysed on Day 29 and used to evaluate if an agent should proceed to Stage 2 of the Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-001 – Master Protocol study. Stage 1 data will additionally be used to determine optimal study endpoints, and the number of patients to enrol into Stage 2 of the study. • Stage 2 of the study (confirmation) is intended to provide confirmatory data of the identified candidate agents from Stage 1, to fully evaluate disease outcomes, including severe adverse events (AEs), overall AEs, disease-related co-infection complications (eg, pneumonia, septic shock), and overall mortality in an expansion stage. Patients and outcomes from Stage 1 will not form part of Stage 2. Some candidate agents will still be in Stage 1 of the study at the point where other candidate agents have progressed to Stage 2. Patients will be randomised to receive one of the candidate agents that is being evaluated at the time of randomisation and whose inclusion/exclusion criteria they meet (as an add-on to SoC) or to a control arm where only SoC is administered. Enrolment of patients will be continuous throughout the study for each candidate agent until the total randomisation number of planned patients for Stage 1 and Stage 2 is achieved. Enrolment under a sub-protocol for a specific candidate agent may also be stopped in the event of success or failure of the candidate agent. The Master Protocol will continue enrolling patients as long as there are candidate agents that are enrolling. Number of Investigators and Study Centres: Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 18 centres and investigators will initially take part in the study. Number of Patients: The expected number of patients for each treatment arm is presented as part of the sample size determination below. It is estimated that up to 1800 patients will participate in the overall study. Treatment Groups and Duration: In each stage of the study, patients will be screened on Day -1 or Day 1, and will remain in the clinic from Day 1 until fit for discharge. Dosing with the candidate agent (as an add-on to SoC) will commence on Day 1. The last day of assessments while hospitalised will be on Day 29. An outpatient visit will be conducted on Day 60 (±4 days), with an end-of-study visit conducted on Day 90 (±6 days). Statistical methods: Sample size determination: Stage 1: Based on the chosen endpoint, a preliminary analysis will be carried out when an estimated 81 events have been observed across each agent treatment and SoC or 28 days after the last patient has been randomised, whichever occurs sooner, as determined by the Independent Data and Safety Monitoring Committee (IDMC). In order to achieve this number of events, it is expected that 54 patients are needed per arm, which will provide 80% power to detect a hazard ratio of 1.6 for the occurrence of the event, when comparing each candidate agent with SoC. To allow for uncertainty in the recruitment rates, it is expected that up to 60 patients will be randomised to each arm in order to achieve the required number of events for the preliminary analysis. Stage 2: The number of patients will be determined more precisely at the end of Stage 1, but approximately 126 patients will be randomised to each arm. Analysis sets: • Intention to Treat (ITT): All patients who are randomised and match the inclusion/exclusion criteria of the Master Protocol and relevant sub-protocol will be included in the ITT. • Safety Set: All patients who are randomised and take at least 1 dose of study medication will be included in the safety set. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-001 – Master Protocol • Pharmacokinetic Analysis Set (PKS): All patients who are randomised and take at least 1 dose of the candidate agent and have quantifiable candidate agent concentrations postdose without protocol deviations or events affecting the pharmacokinetic results will be included in the PKS. • Pharmacodynamic Analysis Set (PDS): All patients who are randomised and take at least 1 dose of study medication (candidate agent or SoC) and have evaluable results for at least 1 pharmacodynamic endpoint postdose. All analyses of the PDS will be based on each patient’s randomised assigned treatment (not actual treatment received). Efficacy, safety, pharmacokinetic, and pharmacodynamic results will be listed and summarised by stage, dose, and scheduled time for the respective analysis sets, where appropriate. Candidate agent concentration versus response variables may be graphically displayed for selected endpoints. Exposure-response data obtained from this study may be combined with data from other studies and used for modelling and simulations. Data Monitoring Committee: A Steering Committee will evaluate interim analysis data to make decisions on further progression of the candidate agents within the study, and will provide guidance, advice, and recommendations to the ACCORD program on relevant clinical issues related to the strategy, implementation, and conduct of the study. An IDMC will objectively monitor safety data throughout the study to make recommendations to the Steering Committee regarding study conduct. Final, 22 April 2020 12 CONFIDENTIAL 1.2 Schema Figure 1 Study Schema ACCORD-2-001 – Master Protocol IA=interim analysis; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SoC=standard of care. Note: This figure shows a hypothetical situation, where in Stage 1 of the study there are 4 candidate agents being compared with the SoC, of which 2 candidate agents progress to Stage 2. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-001 – Master Protocol 1.3 Example Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review of SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria 12-lead Electrocardiogram STUDY INTERVENTION Randomisation Administration of candidate agent Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Day -1 or Day 1 X X X X X X X X X Day 1 X X Xc Daily Until Hospital Discharge Day 15a (±2 days) Defined in subprotocol X X X X Day 29a (±3 days) X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-001 – Master Protocol Screening Baseline Day (± Window) Clinical assessmentsd Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2e SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationf Day -1 or Day 1 X Xg Day 1 Xc Xc X X X X Xc,h Pregnancy test for females of childbearing potential Xg RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis X (others to be defined in sub-protocols) Blood (sodium heparin tube) for PBMC phenotypingi X Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Daily Until Hospital Discharge X X X X X X Days 3, 5, 8, 11 (all ±1 day) while hospitalised Day 8 Day 8 Days 3, 5, 8, 11 (all ±1 day) while hospitalised Day 15a (±2 days) X X X X X X X X Day 29a (±3 days) X X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X X X X X Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-001 – Master Protocol Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) Days 3, 5, 8, 11 (all X ±1 day) while X X hospitalised Saliva for SARS-CoV-2 PCR (qualitative and quantitative) Days 3, 5, 8, 11 (all X ±1 day) while X X hospitalised Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)j X Day 8 X Blood (EDTA) host genome (host DNA)j X Mid-turbinate nasal swab viral genomej X EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. Note: Additional assessments, if required, will be defined in the sub-protocol. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). c Baseline assessments should be performed prior to study drug administration. d Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. e If done as part of SoC, blood gases results to be fully recorded with date and time. f For parameters, see Table 5. Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-001 – Master Protocol g Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. h Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. i Samples collected for immediate laboratory processing and frozen storage. j Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-001 – Master Protocol 2.0 INTRODUCTION 2.1 Study Rationale There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. 2.2 Background Coronaviruses are single-stranded RNA viruses, capable of causing life-threatening disease in humans and animals. The novel coronavirus SARS-CoV-2 was initially identified during an outbreak of viral pneumonia cases of unknown cause in China. Most of the initial infections outside of China were travel associated (ie, from people who had travelled from the infected regions of China to other countries), although person-to-person transmission in other countries was quickly established. The disease caused by the SARS-CoV-2 virus has been designated COVID-19. SARS-CoV-2 binds via the angiotensin-converting enzyme (ACE) receptor located on alveolar cells and intestinal epithelia.1 The virus is mutating, indicating that virulence and transmission will shift over time, and showing diversity in critical surface protein. New evidence suggests there are 2 groups of SARS-CoV-2; L-type and S-type.2 S-type is the less aggressive (30%); the L-type is now the most prevalent version (70%) and is more aggressive. Additionally, individuals appear to be affected to different degree with varying symptoms and outcomes. These findings strongly support an urgent need for immediate comprehensive studies and robust validation of testing methods that combine genomic data, chart records and clinical symptoms, to help better understand the disease, enable risk assessment, triage and support public health resource planning. Due to the rapid global widespread of SARS-CoV-2, there is an urgent need to develop efficacious treatments for the disease. Current clinical studies involve the use of already approved medications for other indications (repurposing) where it is thought that they might also be effective in the treatment of COVID-19 disease, as well as development of antibody-based therapies against the virus. Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-001 – Master Protocol This platform study will test multiple candidate agents, with the aim of identifying potentially efficacious treatments in the shortest timeframe possible. In addition, it will support secondary research objectives that are critical for understanding the disease, spread of infection and robust tests to track it. 2.3 Benefit/Risk Assessment There are currently no approved therapeutic agents available to treat coronaviruses such as SARS-CoV-2, and so while there may not be benefits for an individual patient participating in this study, there may be benefits to society if a safe and efficacious therapeutic agent can be identified during the global COVID-19 outbreak. Detailed information about the known and expected risks and reasonably expected adverse events (AEs) of each candidate agent may be found in the corresponding sub-protocol for that agent. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-001 – Master Protocol 3.0 OBJECTIVES AND ENDPOINTS Table 1 Study Objectives and Endpoints Objectives Primary • Stage 1: To evaluate the efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. • Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID-19 in an expansion stage. Secondary • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. Endpoints • Time to clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses). 9-point category ordinal scale: 0. Uninfected, no clinical or virological evidence of infection 1. Ambulatory, no limitation of activities 2. Ambulatory, limitation of activities 3. Hospitalised – mild disease, no oxygen therapy 4. Hospitalised – mild disease, oxygen by mask or nasal prongs 5. Hospitalised – severe disease, noninvasive ventilation or high-flow oxygen 6. Hospitalised – severe disease, intubation and mechanical ventilation 7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. Death • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-001 – Master Protocol • To evaluate response rate (see primary endpoint for definition of responder). • Response rate (number and %) by treatment arm at Days 2, 8, 15, and 29. • To evaluate time to discharge. • Time to live discharge from the hospital. • To evaluate overall mortality. • Mortality at Days 15, 29, and 60. • Time from treatment start date to death. • Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2), • SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death • To evaluate the safety of candidate agents as • Physical examination. add-on therapy to SoC in patients with COVID-19. • Clinical laboratory examinations. • Vital signs (blood pressure/heart rate/temperature/respiratory rate). • Adverse events. • To evaluate intensive care unit (ICU) and hospitalisation length. • Duration (days) of ICU and hospitalisation. • To evaluate National Early Warning Score 2 (NEWS2). • NEWS2 assessed daily while hospitalised and on Days 15 and 29. • Time to a NEWS2 of ≤2, maintained for at least 24 hours. Exploratory • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). • To collect samples for translational research on • Analysis of samples collected at baseline prior to host and viral genomics, serum antibody treatment and at specific time points. production, COVID-19 diagnostics, and validation of laboratory testing methods. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-001 – Master Protocol 4.0 STUDY DESIGN 4.1 Overall Design ACCORD-2 is a seamless, Phase 2, adaptive, randomisation platform study, designed to rapidly test candidate agents in the treatment of COVID-19 disease. The study will include hospitalised adult patients (≥18 years) who have infection with SARS-CoV-2, the virus that causes COVID-19, as confirmed by laboratory tests and/or validated point of care tests. For inclusion, patients will need to have clinical status of Grade 3 (hospitalised - mild disease, no oxygen therapy) to Grade 5 (hospitalised – severe disease, noninvasive ventilation or high-flow oxygen), as defined by a 9-point ordinal scale, which was detailed in the World Health Organization R&D Blueprint “Novel Coronavirus - COVID-19 Therapeutic Trial Synopsis” (February 2020). Medical history will record the estimated date and time of first symptoms. This study will aim to identify efficacious candidate agents for treatment of COVID-19 disease. These candidate agents may include, but will not be limited to, anti-virals, human plasma-derived agents, or immunomodulatory agents. Experimental (first-in-human) agents will not be considered as candidate agents for ACCORD-2, but will instead be considered for inclusion in the separate, but linked, ACCORD-1 Phase 1/2 platform study, which will first determine the dose and assess early activity and safety signals for later consideration for inclusion into ACCORD-2. The ACCORD-2 candidate agents evaluated will include those intended as a treatment for SARS-CoV-2 infection; the study design and/or inclusion and exclusion criteria may subsequently be revised (using a protocol amendment) or a separate protocol may be initiated to include agents intended to prevent COVID-19 disease. A Steering Committee will evaluate candidate agents for progression in the study (see Section 9.7.1). This Master Protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The Master Protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously. The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation, with the control group for a candidate agent including only patients randomised during the period in which the candidate agent group was randomised, with patients being randomised equally (ie, 1:1:1…) to the sub protocols with inclusion/exclusion criteria that they meet. Sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. The sub-protocols may define adverse events of special interest (AESIs), and can include pharmacokinetic and/or pharmacodynamic assessments that are appropriate for the specific candidate agent (pharmacodynamic assessments may require Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-001 – Master Protocol equivalent blood samples from controls). Additional patients will be recruited into the study each time a new sub-protocol (candidate agent) is added. The study consists of 2 stages: • Stage 1 of the study (evaluation/pilot) will evaluate the candidate agents as an add-on to the standard of care (SoC) to assess preliminary safety and efficacy. A patient will be considered to be a responder if they show an improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, are discharged from hospital, or are considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29. The time to response will be analysed on Day 29 and used to evaluate if an agent should proceed to Stage 2 of the study. Stage 1 data will additionally be used to determine optimal study endpoints, and the number of patients to enrol into Stage 2 of the study. • Stage 2 of the study (confirmation) is intended to provide confirmatory data of the identified candidate agents from Stage 1, to fully evaluate disease outcomes, including severe AEs, overall AEs, disease-related co-infection complications (eg, pneumonia, septic shock), and overall mortality in an expansion stage. Patients and outcomes from Stage 1 will not form part of Stage 2. Some candidate agents will still be in Stage 1 of the study at the point where other candidate agents have progressed to Stage 2. Patients will be randomised to receive one of the candidate agents that is being evaluated at the time of randomisation and whose inclusion/exclusion criteria they meet (as an add-on to SoC) or to a control arm where only SoC is administered. In each stage of the study, patients will be screened on Day -1 or Day 1, and will remain in the clinic from Day 1 until fit for discharge. Dosing with the candidate agent (as an add-on to SoC) will commence on Day 1. The last day of assessments while hospitalised will be on Day 29. An outpatient visit will be conducted on Day 60 (±4 days), with an end-of-study visit conducted on Day 90 (±6 days). Enrolment of patients will be continuous throughout the study for each candidate agent until the total randomisation number of planned patients for Stage 1 and Stage 2 is achieved. Enrolment under a sub-protocol for a specific candidate agent may also be stopped in the event of success or failure of the candidate agent. The Master Protocol will continue enrolling patients as long as there are candidate agents that are enrolling. It is estimated that up to 1800 patients will participate in the overall study. Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 18 centres and investigators will initially take part in the study. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-001 – Master Protocol 4.2 Scientific Rationale for Study Design There are currently no approved therapeutic agents available to treat coronaviruses such SARS-CoV-2, the causative agent of as COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. This study utilises an adaptive design that maximises efficiency in identifying a safe and efficacious therapeutic agent for COVID-19. Some candidate agents may be in limited supply and this study design enables continuation of the study even if an agent becomes unavailable. In addition, the adaptive design allows for the evaluation of new candidate agents as they are identified. 4.3 Justification for Dose Justification for the dose of each candidate agent will be included in the corresponding sub-protocol. 4.4 End of Study Definition For each sub-protocol, the end of the study for that candidate agent will be defined as the date on which the last patient completes the last visit for that sub-protocol. For the overall study, the end of the study will be defined as the date on which the last patient completes the last visit for the final sub-protocol to be concluded. Once a patient has completed this study, there are no restrictions on them entering another study, subject to the eligibility criteria of that subsequent study. Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-001 – Master Protocol 5.0 STUDY POPULATION Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted. The inclusion and exclusion criteria listed below may be supplemented by additional criteria stipulated in the sub-protocols that are specific to the target candidate being tested (eg, criteria related to prohibited medications). In order to enrol, a patient or legally authorised representative must sign an informed consent form (ICF) and meet all entry criteria for both the Master Protocol and at least 1 respective sub-protocol. 5.1 Inclusion Criteria Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests. 2. A score of Grade 3 to 5 on the 9-point ordinal scale. 3. Is a woman who is not of childbearing potential (as defined in Appendix 5) or The patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (eg, barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 6 weeks after termination of study therapy. 4. Ability to provide informed consent signed by the study patient or legally authorised representative. 5.2 Exclusion Criteria Patients are excluded from the study if any of the following criteria apply (or any of the criteria from the appropriate sub-protocol): 1. Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale. 2. Any patient whose interests are not best served by study participation, as determined by a senior attending clinician. 3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN). 4. Known active infection with HIV or hepatitis B or C. 5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate 500 ms. 8. Anticipated transfer to another hospital that is not a study centre within 72 hours. 9. Allergy to any study medication. 10. Experimental off-label usage of medicinal products as treatments for COVID-19. 11. Patients participating in another clinical study of an investigational medicinal product. 5.3 Lifestyle Considerations Any lifestyle considerations that are specific to the candidate agent will be defined in the corresponding sub-protocol. Female patients are advised to avoid becoming pregnant during the study. 5.4 Screen Failures Screen failures are defined as patients who consent to participate in the clinical study but are not subsequently randomly assigned to study treatment. A minimal set of screen failure information is required to ensure transparent reporting of screen failure patients to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory authorities. Minimal information includes demography, screen failure details, eligibility criteria, and any serious adverse event (SAE). Individuals who do not meet the criteria for participation in this study (screen failure) due to hypokalaemia, hypomagnese
Url: /Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-master-protocol.pdf

Your breast prosthesis - patient information

Description: This factsheet explains what a breast prosthesis is, how to care for your prosthesis and when to replace your prosthesis.
Url: /Media/UHS-website-2019/Patientinformation/Womenshealth/Your-breast-prosthesis-4068-PIL.pdf

Recipe book - For toddlers who need to make the most of every mouthful

Description: RECIPE BOOK For toddlers who need to get the most out of every mouthful Contents 04 Acknowledgements & introduction 06 Questions, tips & answers 12 Table 01: Foods which can be used for extra calories and protein 13 Table 02: Examples of exercise and the benefits 14 Food & feeding advice for young children (table) 16 Simple week meal planner 18 Shopping list 20 Recipes: Contents 22 Recipes: Breakfasts � Marvelous nut dust � Granola � Breakfast porridge � Prunes, dates & ground almonds � Peaches, sultanas & ground almonds � Mango & almond butter � Raspberry, banana & almonds 28 Recipes: Power energy balls � Date & apricot power balls 29 Recipes: Warming soups � Dino soup � Super hero orange soup 31 Recipes: Bento boxes � Fusilli, ham, peas & cheese � Ham & cheese pitta & fresh fruit � Ham & cheese sandwich, broccoli, cucumber, orange & nutty chocolate balls � Falafel & hummus pitta, red pepper, cucumber, figs, strawberries � Cream cheese & smoked salmon wheels, avocado & melon � Pitta strips, avocado, hummus, chickpeas, orange peppers � satsumas � Tuna, lettuce, mayo, peas, cucumber, & pepper � Boiled eggs, brown pitta pockets, avocado, watermelon, melon & raspberries � Avocado & raspberries snack fest � Peanut butter, salad & berries � Chicken & BBQ sauce, corn on the cob, cucumber, clementine, & whole wheat wrap � Chicken & cous cous rainbow salad 43 Recipes: Snack boxes 44 Recipes: Meals for sharing � family favourites � Fish fingers & sweet potato chips � Pasta bolognaise � Lasagne � Mild chicken curry � Chicken bunny � Pesto � Salmon, pasta & peas 57 Recipes: Sweet things � Chocolate & almond cup cakes � Apricot, almond & chocolate cereal bars � Nutty flapjacks � Fruit pots � Chocolate peanut butter smoothie � Raspberry & almond smoothie 66 A last note... enjoy... 02 Acknowledgements This book has been written by Dr Luise Marino (RD, PhD) Clinical Academic Paediatric Dietitian at Southampton Children's Hospital. This book is part of independent research arising from (Dr Luise Marino, Health Education England/NIHR Clinical Lectureship (ICA-CL-2016-02-001)) supported by the National Institute for Health Research. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, Health Education England or the Department of Health. In writing this book we have received the generous help and feedback from the following people: � Parents of children who need to make the most of every mouthful � thank you for your time and feedback, without which this book would not be possible � Paediatric Dietitians � Catherine Kidd, Natalie Davies � for your expertise and invaluable comments � Dr Rosan Meyer � for sharing your immense knowledge and skills � Paediatric Speech and Language Therapist � Julia Robinson � for your guidance and practical instruction � Specialist Paediatric Cardiac Liaison Nurses � Gill Harte, Colette Cochran, Cate Anson, Hannah Carver � for your unfailing support, feedback and advice � Dr Tara Bharucha, Consultant Paediatric Cardiologist � for supporting this initiative � Members of the British Dietetic Association Paediatric Cardiology Interest group for their generous help and feedback; in particular Neam Al Mossawi (HCA Healthcare), David Hopkins (Yeovile Hospital) � Dominic and Helen Hoile (info@Shootingpeas.com) � for their generosity opening up their studio and giving of their time to take the photographs. � Heather Pierpoint (headfudgedesign.co.uk) � Graphic designer, for bringing the publication to life � Southampton Children's Hospital Charity and the publishers � Michelle Wheeler, Judith Stephens, Amy McBrayne, Alanna Lee for making it all possible � Nutricia Medical � for supporting the project with an educational grant Dedication For all the families and their children who we are privileged to meet � your stories and journeys inspire us to do better. RECIPE BOOK For young children who need to get the most out of every mouthful Who is this book intended for? This book is intended for children between 1 and 5 years of age. Some children need a little bit longer with puree or fork mashed food so don't worry if your child is not quite at the age stages in this book. Some children are born with medical conditions which means they need to get the most out of everything they eat and drink. For some, whose medical issues may not be such a problem as they were when they were babies, they may now develop feeding difficulties, causing parents just as much concern. This recipe book is part of a series, published by Southampton Hospital Charity, to provide practical advice on how children can get the most of every mouthful. The advice within this booklet may not be suitable for those with delayed oral motor skills, inherited metabolic disorders, kidney problems or food allergies and should not replace individualised medical or nutritional advice. If you are unsure as to whether the advice in this book is suitable for your child, please check with their health care team first. The information in this book was correct, at the time of publishing, and undergoes periodic reviews to ensure up-to-date evidence is used. You should seek advice from your local health care professional if your child is not gaining weight well or is having feeding difficulties. Dr Luise Marino (RD, PhD) Clinical Academic Paediatric Dietitian HEE/NIHR ICA Clinical Lectureship thank you Ask for help If your child is showing signs of feeding difficulties (sensory or oro-motor disorders) which can include coughing, gagging or vomiting at the sight or smell of food or drink, food refusal, eating less than 10 different types of food in a week or you are in any way worried about how your child eats, then ask your child's team to refer you to Dietitian and Speech & Language Therapist for extra support. How will this book help me and my child? The aim of this book is to try and provide some useful tips and advice as well as some finger licking food to tempt your little one with. This book will help give you ideas about: � � � � � � How much to expect your child to eat How often should you expect your child to eat What textures can you expect your child to eat How to create a positive mealtime experience How to cope with stressful mealtimes How to cope with fussy eating 05 Questions, tips & answers... How much should I expect my child to eat? The amount of food young children eat varies from one meal to the next � this is normal. There are lots of resources available providing portion size ranges � with some examples below: � British Nutrition Foundation: https://www.nutrition.org.uk/ attachments/article/734/BNF%20 Toddler%20Eatwell%20Leaflet_OL.pdf � Infant and Toddler Forum https://www.infantandtoddlerforum. org/portion-sizes-table-2015 How often should I offer my child food? Try to have: � Regular mealtimes � aiming for breakfast, lunch and supper � Have at least a 3 hour break between each main meal � this will give them enough time to get hungry, but not too hungry � Try not to offer too many snacks between meals as they may then not be able to eat as much at a main meal � If your child is too tired they may find it difficult to eat, so sometimes lunch may be better after a nap � Offer water to drink at mealtimes � It is alright for your child still to prefer puree food � but continue to try to introduce lumpier and soft finger foods too � This will let children practice their chewing skills try to slowly increase the amount of texture in the meal e.g. 5p � 10p amount of a coarser texture until you have moved onto chunkier and lumpier food � Always give some finger food and a spoon at each mealtime so new skills can be practiced � bite and dissolve foods are good as are other finger foods (see the table at the end of this section for more tips) � Remember all of the senses are involved in eating and drinking; touch, sounds, sight and smells; - We eat food with our eyes, so it is important to make food look good - Touching food is as important as eating, so let your little one get messy - Smells of delicious food can encourage children to eat � Try not to compare how much your little one eats with siblings or other children of the same age � Try not to comment on how much or how well your little one is eating, some children get put off eating by all of the attention and focus on them � Don't follow your child around with a spoon begging them to eat; meals happen as a picnic or at a table not walking around � Encourage your little one to feed themselves; sometimes children like the attention of being fed, but it is good to encourage their feeding skills by letting them do it themselves � Children of all ages like food in boxes � Bento boxes, sandwich boxes or little bags or boxes of food appeal to their growing sense of independence � Food that little fingers can easily pick up is good as they can be more independent � don't worry if they play with it and get messy as this is all part of their learning experience � Eat with them � have a meal or snack at the same time; children learn about eating from those around them so if they see their carers or siblings enjoying the same food as them, they are more likely to try it. It is important that mealtimes are seen as a sociable activity to be enjoyed � If your child gets up from the table then calmly end the meal � there is always the next meal � After a main meal offer a small dessert such as fresh fruit and full fat yogurt, small cup cake and custard Have short mealtimes of up to 20 minutes How do I know when my child has had enough to eat? Let your child tell you when they've had enough � it is really important that you listen to their cues. � As when they were babies, they will start closing their mouth, trying to get down from the table, turn their head away, splay their hands or start spitting, shouting or crying, stop at this point � they are finished � If they say they have had enough to eat � try not to ask them to have a few more mouthfuls, you are teaching them to overeat. Respect their fullness � even if they have only have 1 mouthful Keep offering new food � it will take time before a new food is accepted and liked It can take a while before children will eat new foods � so long in fact that many parents give up! Children are often wary of trying new foods or foods they like that look slightly different e.g. different type of yogurt or packet of pitta bread. Children can take up to 15 tries (or even just looking at something) before they will like something new � for some it can take even longer. Offer regular meals and eat together as this helps children learn that food can be delicious and sociable What general advice is there for encouraging positive mealtimes? � Keep calm and don't rush � some days are better than others � Keep offering new foods � they will eventually try them � Children eat in colour � think of a rainbow when you are making their meals � Children like fun � so make their food look fun � Children like to help and want to please � involve them in the buying, preparing and cooking � Offer small portions and give your child lots of praise and attention when they finish it. You can then offer a second helping What texture should I expect my little one to eat? � Children who are weaned late during the first year of life may have missed some of the milestones for accepting new foods and textures, which can make moving on from smooth puree's harder (but not impossible) � Continue to offer your child lots of different kinds of foods, try not to get put off if they reject new foods If you are finding it difficult to get your little one to accept new textures speak to your child's team Children find sitting still very difficult and get bored quickly � Have short mealtimes of not more than 20 minutes or shorter if your child gets upset and does not want to eat � Use a stop watch on your phone or buy a 15 � 20 minutes sand timer � children like to watch the sand going down and it helps to put a limit on the length of mealtimes � Limit the amount of distractions at mealtimes e.g. electronic devices, television � chatting while you eat is good Mealtimes should be fun! Young children usually live to play, not eat. For many they would much rather be listening to a story or playing than sit down and eat. Therefore, it is important to make mealtimes fun and enjoyable, for the whole family! Don't enter into food battles � if they don't want to eat, don't bargain or bribe them You could try reading books with vegetable and fruit characters such as "mighty broccoli and cheeky cherry", this has been shown to increase young children's interest in tasting new foods. All children are unique � as is their appetite and how much they will eat 06 07 Don't enter into food battles � if they don't want to eat � don't bargain or bribe them Try not to enter into food battles with your little one � they will win! It is important to ensure you serve up child size portions � remember the size of their clenched fist; � If your delicious lovingly prepared mini dish of food is greeted with a "yuk � I am not eating that" � Respect your little ones decision with a "that's fine � you don't have to eat it... but you do have to sit here as it is dinnertime" � The family � even if it is just you and your little one then sit down to a meal � Respect them not eating anything or only eating the thing they like � Always offer a dessert � don't use dessert as a bribe as you are reinforcing the fact the main meal is so "yuk" that a bribe is needed to eat it Fussy eating is really common amongst young children and up to 40% of parents report their child has refused food at some point. Between 12 � 18 months of age, all young children develop "neophobia" � the fear of new food or familiar food offered in a different way. As fussy eating is such a common problem there are lots of tips and advice available � importantly: � Children like to eat with others and will often eat more in a group or when there is a relaxed family environment � Try to eat similar food at meals times to your little one e.g. fork mashed or squares of sandwich � Always, always make some part of the meal you know they will eat, then you know they won't go hungry � Eat with them at the same time � encouraging your child with smiles and positive sounds change or copy other children, so eating with others may not help them to accept new foods or textures � Some children may also have sensory issues and refuse to wear certain clothes or colours. They may also not like to get messy or sticky and dislike seeing people eating food they do not like � which can make them gag or vomit. For these children encourage messy play � This can be done with different kinds and textures of food � Shaving foam is also good fun for your child to put their hands in � Jelly is a great food to play with � wibbly and wobbly � Chocolate pudding on a chopping board for cars to drive through At mealtimes: � Be sensitive to what your child likes and dislikes If this is you: � It is easier said than done, but try to have a relaxed approach to mealtimes � Put the radio on and sing along or listen to a radio programme as it will distract you from the mealtime � Have something to eat at the same time, so your attention is not just on your child. They can also learn to enjoy their food by watching you enjoy it too choking risk children should be sitting whilst eating � Children should not have whole nuts under the age of 5 years � Other hard food, including Granola, should be ground into a finer crumb and not have any hard bits in it � it should also be mixed into food before serving � Always keep crumbed or hard food out of children's reach and always supervise snack or mealtimes � Sometimes doing a child first-aid course can help with any anxiety around mealtimes and choking risks. Ask your Health Visitor to find out what is available near home Most children love to get messy � however, some find it really stressful � so start slowly � outside of mealtimes � Try not to put really disliked food on the same plate as food which is liked � as some children will refuse the whole plate � Away from a mealtime offer tiny tastes of foods that your child might be willing to try � Offer your child different things to smell zest of lemon, herbs, melted chocolate � make a chart and together tick off the smells they like or don't like Children pick up on your non-verbal cues � if they feel you are tense about mealtimes � Don't worry if your child doesn't eat anything � sometimes children aren't hungry for their meals and this is normal � Invite a friend or family member to come and have a few meals with you � as having someone else to talk to can help � Have a picnic instead of eating at the table � you can have an indoor picnic if it is too cold to eat outside � Go out to a caf� and have a drink � offering your child food in a new environment can help My child is really fussy � what shall I do? For some parents feeding their baby has always been easy, but for others their little one's feeding journey has been really challenging � with vomiting, reflux and poor weight gain. As a result of these negative experiences associated with eating, some young children may have developed feeding difficulties or fussiness around food. Some children are fussier than others, but the good news is that with the right encouragement most children will have outgrown being fussy by 6 years of age. Most children love to get messy � however, some find it really stressful � so start slowly � outside of mealtimes � First start with general play with sand and water or paint � Play-doh, kinetic sand and painting are also good tactile games � Once they are comfortable with this take some dry uncooked pasta and place a top on top of the pasta for your child to pick up � Let them see you do it too � Once they are happy with this step, hide the toy in the dry pasta for them to find � Moving on to cool cooked pasta, hide the toy For children who need to gain weight � add nut butters to main meals Children have small tummies (about the size of their fist) so it is tricky to fit a lot in without either making them feel ill, or be sick. Examples of ways to get the most out of each mouthful are as follows; Snacking between meals does not suit all children as it can impact on their hunger and willingness to eat at a main meal. All children are different, so work out whether your child would prefer to have just 3 meals a day or 3 meals and one or two snacks. Snacks can be a useful back up if your child does not eat that well at mealtimes, but don't use snacks to replace main meals. Toddlers usually develop "neophobia", which simply means they don't like new foods � Change only one thing at a time � don't offer too many new foods at once, it can be overwhelming � Do not let new foods touch a favourite food as this can put them off their favourite food � Children who have very strong opinions about food are less likely to accept HELP: I feel really stressed about mealtimes! How can I relax? Our children know us really well. They read our body language and pick up on how tense we are through our faces and the way we sit or stand. For some parents, mealtimes are really stressful and even though they try to smile, their child senses something is wrong... I worry my child will choke � are there any foods I need be careful of? � Peel all fruit and vegetables. Cut round slippery foods length ways into quarters e.g. cherry tomatoes, grapes. As this is a 08 09 For children who need to catch up in terms of growth aim to provide; � Ages 1 � 3 years: an extra 200 � 300kcal, 7.5g protein per day � Ages 4 � 5 years: an extra 300 � 500kcal, 12.5g protein per day Table 1 can be used to plan ways in which to provide extra calories. It is important to use energy-nutrient dense foods e.g. nut butters. For example 6 teaspoons of peanut butter a day is almost 200kcal and 7.5g protein. We do not recommend the addition of extra oil or cream to food � if you have a heavy rich meal it can make you feel sick, children have the same feeling. Instead try to use a teaspoon of smooth nut butters, coconut cream, smooth plain cream cheese or a small pinch of grated cheese. Breakfast: � Add 1 � 2 teaspoons of smooth nut butter (almond, cashew, peanut) to warm porridge or � Toast with 1 � 2 teaspoons of nut butter and marmite or chocolate spread � Add 1 � 2 teaspoons of a nut butter to a home-made fruit smoothie � Add Marvelous nut dust (finely ground) to other breakfast options � mixing it in before serving Lunch and supper: � Offer protein at both main meals such as meat, boneless fish, chicken or beans/lentils with a starch (rice/ potatoes/pasta) and vegetables � add 1 � 2 teaspoons of a smooth nut butter or Marvelous nut dust � A small amount of grated cheese/ cream cheese can be added to mashed potato or meat dishes, instead of a smooth nut butter � Following a meal offer - Fruit or full cream yogurt - Full cream custard with a small cup cake - Rice pudding with 2 teaspoons of chocolate nut butter - Mashed avocado with toasted pistachio dust mixed into the avocado Eating veggies � children need to see you eating them too We all like sweet foods, so for many people veggies may not be their first choice of food. We should all eat 5 or more portions of fruit and vegetables a day. Some children really struggle with veggies, so here are some tried and tested tips; � Children need to see you enjoying veggies � so cook your favourites and eat them as a snack or with your meal � Most children 3 years and above like frozen peas � put a small amount in a pot and offer them whilst they are still frozen � Chop leafy veg such as kale and cabbage into really small bits � Cook leafy veggies with some chicken, pancetta or add a little gravy to give it a more savoury taste � Eat the same veggies as your children � Put mayo or tomato ketchup on salad � Don't insist they try it � all you can do is make it look yummy � Make up fun names � rocket man, pirate peas, beautiful butternut � Look for video clips of other children eating vegetables � Play with veggies � getting them to tear it, wash it, mash it � Take veggies selfies � Start with 1 teaspoon of a new veggie on their plate or side plate Continue with positive touch, massage and encouraging smiles � this all helps to reinforce positive messages about food. It is a good idea to start brushing your child's gums and teeth from when you see the first tooth. � Try not to let young children fall asleep with a bottle of milk in their mouth � offer milk before they go to bed, brushing their teeth afterwards � Use a toothpaste containing fluoride � it should have 1,350�1,500 parts per million (ppm) fluoride � Below the age of three years, children only need just a smear of toothpaste � Children aged 3 to 6 should use a peasized blob of toothpaste � Under the age of 7 years old you should brush your child's teeth for about two minutes twice a day: once just before bedtime and at least one other time during the day � Make tooth brushing as fun as possible by using an egg timer to time it for about two minutes � Don't let children run around with a toothbrush in their mouth, as they may have an accident and hurt themselves STEP 1 If your child is gagging or retching at new food on their plate, to begin with put a small amount e.g. 1 cooked carrot finger stick on a plate in the kitchen STEP 2 Encourage your children to be active � do activities as a family All children and young people should engage in `moderate to vigorous' physical activity for at least 60 minutes every day. You should also try to include some `light' activity and some `strength' activity.' It is important when doing sport that you exercise your whole body in a fun way! Why is it important to be active for at least 60 minutes each day? When they are able to look at it away from the table � put the new food on a plate in the middle of the table Don't comment on the food, just leave it there STEP 3 Once this has been accepted, move the plate closer to their plate � again don't comment or ask them to try it Make food fun Green soup can become "super hero" soup � add crispy croutons on top, serve it in little tea cups and just leave it for them to look at. If children see you eating something and enjoying it � they will eventually try it. Role playing about food outside of mealtimes, shopping games, helping with cooking such as passing vegetables is a good way of engaging children. Watching cooking programmes and talking about food, describing the smell and taste whilst you watch can help. Making colourful meal boxes � Pick a colourful Bento box/food container STEP 4 As they get more comfortable with the idea of a new food, then put a small amount on their plate e.g. 1 broccoli stem � they don't need to try it Brush your child's teeth at least twice per day � Helps keep our hearts and muscles healthy � Helps us keep a healthy weight � Improves bone health � Improves self-confidence and self-esteem � Develops new social skills and meet new people STEP 5 Once they are happy with the new food on their plate � ask them if they would pick it up and smell it Help teach your child how to brush their teeth properly � There are some fun clips on brushing children's teeth https://www.youtube. com/watch?v=kuLxz5IrZ6Y � Guide your child's hand so they can feel the correct movement � Use a mirror to help your child see exactly where the brush is cleaning their teeth STEP 6 After smelling, move to licking � then a small bite, they are allowed to spit it out � then to progress to swallow It can take weeks to get to this point � after a while the process will get easier and it will be quicker Make food fun � give dishes fun names... � Use colourful food picks to make a mealtime fun � Add edible cartoon eyes to food � Use a brightly coloured silicone muffin cup 10 11 Table 1: Foods which can be used for extra calories and protein Food item < 50 kcal 1 teaspoon chocolate spread 1 heaped teaspoon cream cheese 50�100 kcal 2 teaspoons smooth peanut butter Bacon � lean rasher Fruit smoothie 1 tablespoon Marvelous nut dust (see page 22) 100�150 kcal Egg, (1) scrambled with milk Chicken, drumstick Cubes of cheese 150�200 kcal Avocado, half 75g 183 1 Yogurt, full fat 175ml 180 7.7 60g 40g 45g 105 110 150 6.2 11 10 Meatball, small Milk, full cream Baked beans 60g 200ml 125g 125 125 116 16 6.4 6 10g 40g 150ml 15g 100 2.3 58 69 2.4 12.9 Egg, boiled Raisins � small box Banana Olives (cut in half lengthways) 60g 27g 100g 10 88 88 92 60 7.6 0.86 1.3 <0.5g 5g 10g 15 34 0.8 0.6 1 teaspoon peanut butter Cheese (pinch) 5g 10g 29 35 1.2 2 Table 2: Examples of exercise and the benefits Amount Energy (kcal) Protein (g) Exercise Light Amount Energy (kcal) Protein (g) Food item What is it and how does it help your body? This won't make you hot or sweaty. It gets your body moving and is a great way to get into doing more physical activity if at the moment you don't do very much. This will make you feel warmer and breathe harder. You should feel your heart beating faster, but still be able to carry on a conversation. This exercise is good for your heart. Examples � Walking � Playground activities Moderate � � � � � � � � � � � � � � � � � Walking Playground activities Slow swimming or playing in the water Riding a scooter Skateboarding Roller blading Riding a bike on flat ground or with very few hills Riding a horse Running or playing running games such as `stuck in the mud' Swimming Team sports such as Hockey / Basketball / Football Fast cycling or on hilly terrain Swinging on playground equipment Hopping and skipping Sports such as gymnastics or tennis Playground games such as `tug of war' Rock, rope or tree climbing Vigorous * This will make you out of breath and possibly red in the face, making it more difficult to carry on a conversation. This type of exercise is good for your heart. Strength This helps to make your bones and muscles strong. * if you are not sure check with your health care team before you do anything that is very vigorous HELP: none of this advice is working If you are finding any aspect of introducing food difficult or your little one is showing signs of not wanting to eat at all � don't suffer in silence � your child's team can help. 12 13 Food & feeding advice for young children Food and Feeding Advice Type of food to offer If you are making food at home, try some of our recipes in this book. From 12�18 months of age � Continue with your child's usual milk or a nutrient energy dense infant formula around 12 � 16oz � Main meals should include protein e.g. chicken, fish, beans, lentils, meat along with veggies and starch e.g. potato, rice, pasta � If your child needs to gain weight add 2 teaspoons of smooth nut butter to each meal including porridge at breakfast � Keep offering new foods � although it should not touch any favourite food � At this age children start not to need as many calories to gain weight as they did when they were babies � Eats ground, mashed, or chopped table foods (including soft pieces of meat chopped cut up very small) by 15 months � All finger food should still be soft, must fit easily into your child's hand and be just the right size to easily fit into your child's mouth � Know when your child has had enough � signs include starting to play with food, tries to get out of their high chair From 19�24 months of age � Continue with your child's usual milk or a nutrient energy dense infant formula around 10 � 12 oz � Main meals should include protein e.g. chicken, fish, beans, lentils, meat along with veggies and starch e.g. potato, rice, pasta � If your child needs to gain weight add 2-3 teaspoons of smooth nut butter to each meal including porridge at breakfast � Keep offering new foods � although it should not touch any favourite food � Food refusal of favourite or new foods is common around this age � your child will start to show clear likes and dislikes � Chopped texture, small soft pieces including adult style foods � Offer foods with a firmer texture to promote chewing skills � At this age children chew with up/ down and side to side action � All finger food must fit easily into your child's hand and be just the right size to easily fit into your child's mouth � Know when your child has had enough � signs include starting to play with food, tries to get down from the table � Encourage sitting at the table � children should not be walking/running when eating � Encourage the use of small child size utensils e.g. fork, spoon � Is able to feed themselves using a spoon � with less spills � Able to keep their mouth closed when chewing and swallowing � Start to stab food with a fork and get it to the mouth � Should have adult supervision at meal/ snack times � Some young children start to eat very fast � encourage them to eat slowly chewing their food � Mealtimes should last for up to 20 minutes From 2 years to 5 years of age � Continue with your child's usual milk or a nutrient energy dense infant formula around 10 � 12oz � Main meals should include protein e.g. chicken, fish, beans, lentils, meat along with veggies and starch e.g. potato, rice, pasta � If your child needs to gain weight add 2�4 teaspoons of smooth nut butter to each meal including porridge at breakfast � Keep offering new foods � although it should not touch any favourite foods � May become a "fussy eater" refusing foods that were previously liked � By three years of age your child should be able to eat the same foods as the rest of the family � All finger food must fit easily into your child's hand and be just the right size to easily fit into your child's mouth � Know when your child has had enough � signs include starting to play with food, tries to get down from the table Food and Feeding Advice Finger foods From 12�18 months of age � The best types of foods to start off with are ones that dissolve easily e.g. sweetcorn puffs. � Dissolving foods melt evenly in the mouth without leaving lumps e.g. wotsits � These types of food help with chewing skills as your little one needs enough skill to be able to hold the food in the mouth until it melts � Other good finger foods to then move onto are steamed well cooked carrots sticks, banana, avocado, soft pear, soft flaky fish, toast finger, pasta shells All finger food should be soft, easily fit into your child's hand and be just the right size to easily fit into their mouth. Cooked soft finger shaped foods are helpful rather than round shapes. From 19�24 months of age � Even with finger foods children should be sat down � they should never eat and walk/run � As your child's skills increase they will be able to manage different types of soft food � It is sometimes useful to offer these foods as in between meals snacks so you and your little one can enjoy them exploring new foods and textures together All finger food should be soft, easily fit into your child's hand and be just the right size to easily fit into their mouth. Cooked soft finger shaped foods are helpful rather than round shapes. From 2 years to 5 years of age � Always sit with your children when they are eating any food including finger foods � As a snack offer soft cooked vegetables and dips in small pots � It is sometimes useful to offer these foods as in between meals snacks so you and your little one can enjoy them exploring new foods and textures together All finger food should be soft, easily fit into your child's hand and be just the right size to easily fit into their mouth. Cooked soft finger shaped foods are helpful rather than round shapes. Textures Choking hazards Mealtimes � Should sit on a high chair � Is able to feed themselves using a spoon � although expect some food to drop off � It is common for a little bit of food or saliva to still fall out of their mouth � Encourage self feeding � Should have adult supervision � Offer drinks from a sippy cup � Should have adult supervision at meal/ snack times � Mealtimes should last for up to 20 minutes � Encourage sitting at the table � children should not be walking/running when eating � Your child will have definite food likes and dislikes and may refuse certain foods � Continue to encourage new foods � which may take 15 tries before being accepted � Drinks from a cup or beaker � Encourage independent feeding using small child size utensils e.g. fork, spoon � A spoon and fork should be held between the fingers palm up. Introduce a child size knife for practice � Should have adult supervision at meal/ snack times � encourage slow eating � Mealtimes should last for up to 20 minutes � Some types of food are a choking hazard and should be avoided in babies and young children � This list may not included everything � so it is important that you sit with your little one at each meal & snack time � Young children should be encouraged to sit down and eat rather than run around � Hard lumps of any size should be avoided � Raw vegetables are often hard � so offer soft cooked sticks e.g. carrot, courgette and celery � Hard pieces of raw fruit such as apple and pear should not be given � Avoid slippery foods such as pieces of canned fruit � cut them up into small pieces or mashed e.g. sweet corn kernels; � Hard lumps of any size should be avoided in children under the age of 3 years, as they require very developed chewing skills. � Raw vegetables, hard or stringy meat, hard peas and beans, hard dried fruit, toasted or hard sugar syrup coated cereals and `granola' type products and hard crisp or chip products are all examples of foods that should be avoided. � For toddler and young children all finger foods should be cut in short thin stick e.g. lengthways rather than then being round in shape, as this reduces the risk of choking - Mini sausages / mini scotch egg balls - Cut whole grapes, berries, cherries, melon balls, cherry / plum tomatoes lengthways into quarters - Cut orange / satsuma segments into quarters � take the pips out - Chunks of fish flaked should be checked for bones * Suggested feeding times: 8-9 am, 11-1 pm, 4-5pm with milk before or with breakfast and just before bedtime (ensure you brush you little children's teeth at least twice a day e.g. after breakfast and before bed) 14 15 Simple week meal planner From 12 months of age Day With or before breakfast Child's usual milk Breakfast Mid morning Lunch Evening meal Before bed Child's usual milk MONDAY Porridge with milk, peaches & granola (ground into a fine crumb) Vegetable sticks & hummus Mini packed lunch* Meat, chicken or fish based ready prepared child's food Fruit pot Meat, chicken or fish based ready prepared child's food Yogurt Meat, chicken or fish based ready prepared child's food Oat based pudding Meat, chicken or fish based ready prepared child's food Fruit pot Meat, chicken or fish based ready prepared child's food Fruit pot Meat, chicken or fish based ready prepared child's food Oat based pudding Meat, chicken or fish based ready prepared child's food Custard TUESDAY Child's usual milk Toast with smooth peanut butter & banana Porridge with milk, peaches & ground almonds Toast with smooth almond butter & jam Grated cheese, cherry tomatoes & grapes Asparagus wrapped in ham Mini packed lunch* Child's usual milk WEDNESDAY Child's usual milk Mini packed lunch* Child's usual milk THURSDAY Child's usual milk Broccoli, olives & breadsticks Mini packed lunch* Child's usual milk FRIDAY Child's usual milk Porridge with milk & dates, prunes Baby sweetcorn, mange tout & avocado Baby sweetcorn, mange tout & avocado Vegetable sticks & mashed avocado Mini packed lunch* Child's usual milk SATURDAY Child's usual milk Toast with smooth peanut butter & marmite Porridge with milk, raspberry & ground almonds Mini packed lunch* Child's usual milk SUNDAY Child's usual milk Mini packed lunch* Child's usual milk NOTES: A. Children between the ages of 1 and 3 need to have around 350mg of calcium a day. About 300ml of milk will provide this. Non-dairy calcium enriched drinks may also be used. B. All round or slippery foods e.g. olives, cherry tomatoes, grapes, cucumber should be cut lengthways into thirds or quarters. Where possible they should also be peeled. C. Children should eat sitting down and be supervised at all times whilst eating D. Hard foods such as carrots should be lightly cooked E. *Mini packed lunch � see the recipes for lunch boxes below � these can be adapted for the age of your child and what textures of food they can eat e.g. fork mashed F. If your child needs to gain weight add: 1 � 2 teaspoons of Marvelous nut dust or smooth peanut butter to each main meal 16 17 Shopping list For the recipes you can buy fresh, frozen or tinned fruit and vegetables. All of these ingredients are available in budget as well as other supermarkets. Fr ui t & Ve gg ies � Frozen pe as ixe d pe pp ers � Frozen /f re sh m rn � Frozen swee t co rrot s � Frozen /f re sh ca sh, ge m sq ua sh � Bu tter nu t sq ua swee t po tato � Swee t po tato, ble Ka le, ca bb age, � Al l gree n ve ge ta urge tte, gree n Br us se l Spro uts, co ga r sn ap pe as, be ans, cucum be r, su li, runner be ans m ange to ut, broc co pa rs ni ps � Swede, tu rn ip s, s , pi ne apple , ch er rie � Banana, m ango es ache s, ne ctar in (withou t stones), pe � Av oc ado spbe rr ies � Frozen /f re sh ra ue be rr ies � Frozen /f re sh bl ango � Frozen /f re sh m in ju ice � Ti nned pe ache s ju ice � Ti nned pr unes in ric ot s � Re ad y to eat ap � Su lta na s Nut bu tters (n o adde d suga r va rie tie s) � Smoo th pe an ut bu tter � Smoo th ca sh ew bu tter � Smoo th almon d bu tter Pu ls es & grai ns � Ch ic kp ea, be an or gram flo ur � Ti nned ch ic kp ea s � Le nt ils � gree n an d re d � Grou nd almon ds � Q ui no a Oi ls � Co co nu t crea m � Ol ive oi l Fi sh & meat � Whi te or oi ly fish � Lam b � Be ef � Ch ic ke n He rb s & sp ice s in t � Frozen /f re sh m ri an de r � Frozen /f re sh co nger � Frozen /f re sh gi ic � Grou nd tu rmer namon � Grou nd cin 18 19 Recipes � Breakfasts � Power energy balls � Warming soups � Bento boxes � Family favourites � Sweet things 20 21 Marvelous nut dust This Marvelous nut mix is bursting with goodness � nutritious nuts are rich in protein, fats, energy and micronutrients. For those who are trying to make the most out of every mouthful use the Marvelous nut dust on cereal in the morning, an added crunch to a pitta pocket or sprinkled on pasta and rice dishes to provide an unexpected flavour burst. The Marvelous nut dust can be spiced up with some dried chili flakes. Granola Ingredients � � � � � 100g Pistachios 100g Almonds 100g Pecan nuts 100g Walnuts 100g Brazil nuts Other kinds of nuts that can be included: � � � � Macadamia Hazelnuts Chestnuts Peanuts Ingredients � � � � � � 300g oats 200g chopped nuts (almonds, pistachio, hazelnuts) 50g dried apricots 45g (3 tablespoons) golden syrup 2 tablespoons of olive oil � teaspoon vanilla extract Method 1. Where possible buy ground nuts e.g. ground almonds 2. For whole nuts, use a hand held blender or mini food processor to blitz the nuts into a fine dust. For larger nuts such as Brazils cut into pieces before blitzing 3. Store in an airtight container Method 1. Heat the oven to 200oC / 180oC fan / gas mark 6 2. Add all of the ingredients to a mixing bowl and stir until everything is covered in golden syrup/oil � it may be easier to mix using your hands 3. Spread the mixture in a thin layer on a baking sheet (use greaseproof paper) 4. Bake for 10 minutes until lightly toasted 5. Cool before storing then crumble into small pieces 6. Store in an airtight container for up to 2 weeks Nutrition content per 100g 655 kcal / 14.5g protein Serving suggestion 1 tablespoon = 15g � 100kcal / 2.3 protein Serving suggestion Important to note: � For children under the age of 5, nut dust should be ground into a fine crumb with no hard lumps or chunks of nuts which may be a choking hazards � As there is a choking risk with crumbs, it is also important the nut dust is mixed well into food and not offered only as dust � The nut dust should be kept in a sealed container out of the reach of young children � If your child has a nut allergy do not use the Marvelous nut dust in food. If there is a history of nut allergies in the family and you are unsure if your child can tolerate nuts, please discuss nut introduction with your Health Care Professional. Add 2 � 3 tbsp to your usual cereal and milk Important to note: � For children under the age of 5, Granola is not suitable and should be ground into a fine crumb with no hard lumps or chunks which may be a choking hazards � As there is a choking risk with fine crumbs, it is also important the granola crumb is mixed well into food. � The granola should be kept in a sealed container out of the reach of young children. 22 23 Breakfast porridge Ingredients � 50g rolled oats � 300ml full cream milk or your child's usual milk � Pinch of salt Prunes, dates & ground almonds Ingredients � 150g tinned prunes in juice � 30g ready to eat apricots � 20g (2 tablespoons) ground almonds Method 1. Place the tinned prunes and ready to eat apricots (approximately 8) with the prune juice in a pan and simmer on a low heat for 5 minutes or until the fruit is soft 2. Add in 20g or 2 tablespoons of ground almonds 3. Using a stick blender, puree ingredients until smooth 4. Portion into ice cube trays Method 1. Add the oats and full cream milk to a pan 2. Place on a medium heat 3. As the mixture starts to bubble, stir well 4. Once it is thick, take off the heat and serve in a bowl 5. Add your favourite topping (from the following pages) and eat whilst warm Serving suggestion 2 � 3 cubes added to your porridge Important to note: � Instant porridge can be used following manufacturer's instructions, rather than making your own � If you don't like hot porridges you can add one more of the toppings below to your usual cereal with milk, to which you can add a dollop of yogurt 24 25 Peaches, sultanas & ground almonds Ingredients � 150g tinned peaches in juice � 30g sultanas � 40g (4 tablespoons) ground almonds Mango & almond butter Ingredients � 200g fresh mango � 30g (6 level teaspoons) almond butter Method 1. Peel and chop the fresh mango into chunks 2. Place in a bowl along with 30g smooth almond butter (6 level teaspoons) 3. Using a stick blender, puree until smooth 4. Portion into ice cube trays Method 1. Place the tinned peaches, juice and sultanas in a pan and simmer on a low heat for 5 minutes 2. Add in 40g or 4 tablespoons of ground almonds 3. Using a stick blender, puree until smooth 4. Portion into ice cube trays Serving suggestion (both) Serving suggestion 2 � 3 cubes added to your porridge 2 � 3 cubes added to your porridge Raspberry, banana & almonds Ingredients � 200g fresh or frozen raspberries � 200g banana � 50g ground almonds Method 1. Peel and chop the banana into chunks 2. Put the raspberries into a bowl along with the banana and ground almonds 3. Using a stick blender, puree until smooth 4. If the puree is a little thick add a splash of almond milk/whole milk 5. Portion into ice cube trays 26 27 POWER ENERGY BALLS Date & apricot power balls These are great for little mouths as between meal snacks or as part of a dessert with some fresh fruit. Dino soup Ingredients � � � � � � � WARMING SOUPS Method � � � � � 500ml water 150ml single cream 1 tablespoon of olive oil Salt and pepper Home made croutons e.g. soft bread cut into small cubes 1. Heat the oil in a large saucepan over a medium heat 2. Add in the finely chopped celery, onion and cook until soft 3. Add in the broccoli, courgettes, peas, basil, chicken stock and water 4. Bring to the boil and cook until the vegetables are tender (5 minutes) 5. Using a stick blender carefully blend until the soup is smooth 6. Add in the single cream and seasoning 7. Serve the soup in bowls or teacups, sprinkle with croutons � this makes a great between meal snack Ingredients � 250g walnuts or ground almonds, or other nut/seed of choice � 250g shredded unsweetened coconut � 320g soft Medjool dates, pitted � 2 tablespoons sunflower oil � � teaspoon sea salt � 1 teaspoon vanilla extract 400g broccoli 400g frozen peas 400g courgettes 2 sticks of celery 2 onions finely chopped Small packet of basil 500ml chicken stock Important to note: � For children between the ages of 1 � 3 years of age, offer small cubes of soft bread dipped in the soup instead of ready to eat croutons which are too are too hard for young children and may pose a choking risk. Method 1. Roughly chop the dates 2. Keep � of the coconut to one side in a bowl for rolling the balls in, to coat them in coconut 3. Put all of the ingredients into a bowl. Using a hand held whisk or food processor blitz until it is a smooth paste 4. Take a teaspoon or tablespoon of mixture (depending on the size of ball you want) and roll into a ball 5. Roll the ball in the coconut 6. Place on parchment or greaseproof paper 7. When finished rolling the balls, put them in a greaseproof paper lined container and put them in the freezer 8. Pop a few in a snack box or as a dessert � can be eaten frozen! 28 29 Super hero orange soup Ingredients � � � � � � � � 800g butternut squash 400g sweet potatoes 2 sticks of celery 2 onions finely chopped Small packet of coriander 500ml chicken stock 500ml water 50ml orange juice � 150ml coconut cream � 2 tablespoons nut butter � Small pinch of chili (optional) � 1 tablespoon of olive oil � Salt and pepper � Home made croutons e.g. soft bread cut into small cubes WARMING SOUPS Bento boxes Method 1. Heat the oil in a large saucepan over a medium heat 2. Add in the finely chopped celery, onion and cook until soft 3. Add in the butternut squash, basil, chicken stock, orange juice, coconut cream, chili (optional), seasoning and water 4. Bring to the boil and cook until the vegetables are tender (25 � 30 minutes) 5. Using a stick blender carefully blend until the soup is smooth 6. Serve the soup in bowls or teacups, sprinkle with home-made croutons � this makes a great in between meal snack Important to note: � Use home made croutons using small cubes of soft bread. Ready to eat croutons are too hard for young children and may pose a choking risk. 30 31 BENTO BOXES Fusilli, ham, peas & cheese Ingredients � � � � � � Photo 1 Ham & cheese pitta & fresh fruit Ingredients � Small toasted wholemeal pitta, cut into strips � Handful of grated cheese � Slice of ham � Olives � Red pepper � Passion fruit, figs, grapes (or other seasonal fruit) BENTO BOXES � Edamame or green beans 50g fusilli � Pomegranate seeds 1�2 slices of ham � Grapes 25g frozen peas � Pear 30g grated cheese Carrots ribbons 1 teaspoon Marvelous nut dust Method 1. Cook some fusilli in boiling water until al dente (has a bite to it), add the peas and cook for a further 1 � 2 minutes 2. Whilst the pasta is cooking shred the ham and grate the cheese 3. To the hot drained pasta add the ham, Marvelous nut dust and grated cheese mixing well 4. Using a vegetable peeler make some carrot ribbons 5. Take 10 � 15 edamame beans and thread onto a food pick or plastic skewer 6. Cut the fruit lengthways, add a few pomegranate seeds 7. Put into the bento box Photo 3 Photo 2 Method 1. Arrange the pitta strips in the Bento box with the ham and grated cheese 2. Put the olives, cut length ways in half or quarters with the lightly steamed red pepper pieces 3. Arrange the fresh fruit in the other side of the Bento box, peel and cut grapes length ways in half or quarters 4. Use a child size soft teaspoon to scoop the inside of a fig or passion fruit (Photo 3) Photo 4 Important to note: � All vegetable and fruit should be washed before eating � Lightly steam hard vegetables � All vegetables and fruit should be cut length ways into small pieces, and some will need to be peeled � Recipes can be change to inclu
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