Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr GASTRIC-PICU Team
-
gastric@icnarc.org


Prof Lyvonne Tume
+44 (0)7710412142
Lyvonne.tume@edgehill.ac.uk


Ms Irene Chang
+44 (0)204 513 6249
irene.chang@icnarc.org


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - No routine measurement of gastric residual volume in paediatric critical care

No routine measurement of gastric residual volume in paediatric critical care

Medical Conditions

Oral and Gastrointestinal


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Most children in intensive care cannot eat normally by mouth and require feeding into their stomach via a tube (a nasogastric (NG) tube or gastrostomy). It is important to provide enough calories to children through their feeds while they are critically ill, as this can help them to get off the ventilator faster, improves how quickly wounds heal and generally helps them to recover better from their illness. Ensuring children in intensive care have enough calories from feeds is a big challenge. We know from large worldwide studies that most children in intensive care get only around half of the calories they need. This is mainly due to their feeds being stopped. The most common reason is that the amount of fluid in the stomach is felt to be ‘large’. Across the UK, it is a common practice in all Paediatric Intensive Care Units (PICU) for nurses to check how much food is in the stomach. A syringe is attached to the end of the feeding tube and the child’s stomach contents are gently ‘sucked out’. This is to see how much fluid is in the child’s stomach and see how well the child is digesting their feed. This is called the gastric residual volume or GRV, often referred to as an ‘aspirate’. If a child has a ‘large’ GRV, often feeding is stopped. However, the amount of fluid in the child’s stomach is affected by many things, not just how much we feed them, but also how much gastric juice their stomach produces and some of the medicines we use slow down the stomach’s actions. The measurement of this (GRV) through the NG tube or gastrostomy is known to be quite inaccurate. Therefore, a decision may be taken to stop feeds, or not to increase feeds, when there is no need to. We do not know whether it is better to measure GRV routinely or not and this is why we are doing this study. This study aims to determine the clinical and cost-effectiveness of no routine GRV measurement to guide enteral feeding and to determine if it is non-inferior to standard at least 6 hourly GRV measurements in mechanically ventilated children admitted to PICU.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

29 Jun 2023 01 Aug 2025

Half of the children in the study will be assigned to the routine GRV group where their stomach contents will be measured at least every 6 hours, the common practice in most paediatric intensive care units in the UK to control for feed intolerance or the stomach getting too full. The other half of the children will not have this done and instead will be monitored for feed intolerance/stomach fullness using clinical signs only.


Children who are mechanically ventilated and tube fed, who are aged at least 37 weeks corrected gestational age and less than 16 years

You can take part if:



You may not be able to take part if:


1. Post-pyloric feeding or jejunostomy 2. End-of-life care plan in place with limitation of resuscitation 3. Children on long-term mechanical ventilation 4. Current or recent gut pathology or surgery (e.g., necrotising enterocolitis (NEC), active GI bleeding, or any intestinal surgery)5. Known to have been enrolled in the GASTRIC-PICU trial in the last 6 months


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NHS Lothian
    Waverley Gate 2-4 Waterloo Place
    Edinburgh
    EH1 3EG
  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
    Glasgow
    G12 0XH
  • Freeman Road Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge Biomedical Campus Hills Road
    Cambridge
    CB2 0QQ
  • Belfast Health and Social Care Trust
    Trust Headquarters A Floor - Belfast City Hospital Lisburn Road
    Belfast
    BT9 7AB
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • Manchester University NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • Guy's and St Thomas' NHS Foundation Trust
    St Thomas' Hospital Westminster Bridge Road
    London
    SE1 7EH
  • University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Trust Headquarters Marlborough Street
    Bristol
    BS1 3NU
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Queens Medical Centre
    Derby Road
    Nottingham
    NG7 2UH
  • Great Ormond Street Hospital for Children
    Great Ormond Street
    London
    WC1N 3JH
  • Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • St Georges Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • Birmingham Women's and Children's NHS Foundation Trust
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Sheffield Childrens NHS Foundation Trust
    Western Bank
    Sheffield
    S10 2TH
  • NHS Staffordshire and Stoke-On-Trent Integrated Care Board
    1 Staffordshire Place
    Stafford
    ST16 2LP
  • Alder Hey Childrens NHS Foundation Trust
    Eaton Road West Derby
    Liverpool
    L12 2AP
  • The Royal Belfast Hospital for Sick Children
    274 Grosvenor Road
    Belfast
    BT12 6BA

While the research team cannot guarantee that taking part in this study will benefit the participants, they may receive more of their required calorie (energy) needs from their feeds, which is important for recovery and reducing the length of illness. Also, by being in this study there will be a more detailed observation of the child’s calorie and feed intake, along with other things such as the time they spend on the breathing machine. If a child is selected to have their GRV measured, they will be receiving standard UK care, so there will be no difference from ‘usual care’. If a child is chosen at random to ‘no GRV measurement’ the risk is that the child’s stomach might get full, and they might vomit and inhale this vomit into their lungs. However, this risk has never been proven. There is also a risk that when GRV is aspirated and returned into the child’s stomach, this may also cause vomiting. This will not take place in the no GRV group. Small studies have not found any additional risks in children who did not have their GRV measured regularly, and in some countries (France) GRV is not routinely measured.

Ms Irene Chang
+44 (0)204 513 6249
irene.chang@icnarc.org


Dr GASTRIC-PICU Team
-
gastric@icnarc.org


Prof Lyvonne Tume
+44 (0)7710412142
Lyvonne.tume@edgehill.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Intensive Care National Audit & Research Centre and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN79668198

Or CPMS 54988

Last updated 20 May 2024

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