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The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care

About one in seven babies in the UK needs specialist hospital care. Premature babies born six or more weeks early are often fed milk through a soft tube into their stomach. Currently, some neonatal doctors and nurses regularly check how much milk is left in the baby's stomach before the next feed. Others believe these checks are uncomfortable, unnecessary, and might delay feeding. The neoGASTRIC trial involves around 7,000 babies across the UK and Australia. It compares regular stomach checks against no routine checks to see which approach helps babies reach full milk feeds faster and more safely. Both methods are already standard NHS practice. The study uses an 'opt-out' approach, meaning eligible babies take part automatically unless their parents choose not to. Parents can opt out at any time without affecting their baby's medical care.

At a glance

Status
Completed
Sponsor
Imperial College London
Enrolment target
7,040
Start
01 Apr 2023
Estimated completion
28 Feb 2026

What is this study about?

When a baby is born early, their tummy and bowels are not yet ready to take full milk feeds right away. Because of this, they are fed small amounts of milk through a soft plastic tube placed through their nose or mouth into their stomach. Doctors and nurses slowly increase the milk feeds as the baby grows.

Across NHS neonatal units, there are two common ways to manage tube feeds. In some units, nurses regularly use a syringe to draw out and measure any leftover milk in the stomach before the next feed. Some doctors believe this helps spot serious tummy illnesses early, such as a severe bowel inflammation called necrotising enterocolitis (NEC). However, other doctors believe these regular checks are unpleasant for the baby, inaccurate, and may needlessly delay feeding.

The neoGASTRIC study aims to answer which approach is best. By comparing routine checks with not checking routinely, researchers hope to see if babies can safely reach full milk feeds sooner. Reaching full milk feeds earlier may also reduce the need for feeding drips through a vein and lower the risk of infection.

Key takeaways

  • Open to babies born at least six weeks early who are fed through a tummy tube.
  • Compares two standard NHS feeding methods: checking stomach milk regularly versus not checking routinely.
  • Aims to discover if skipping routine checks helps babies safely reach full milk feeds faster.
  • Involves no extra hospital visits, scans, or blood tests.
  • Uses an opt-out system, meaning parents can withdraw their baby at any time without any impact on their care.

Who may be eligible?

This study is designed for babies who are born at least six weeks early (before 34 weeks of pregnancy) and who need to receive milk through a feeding tube into their stomach. To take part, babies must be in the early stages of feeding and not yet receiving larger amounts of milk.

Babies cannot take part if they have had major bowel surgery, have suspected serious gut conditions, or have major birth defects. Babies will also not take part if their doctors believe they are too unwell to survive, or if a parent chooses to opt out.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Baby born before 34 weeks of pregnancy (at least 6 weeks early)
  2. Feeding tube placed through the nose or mouth into the stomach
  3. Not yet on large volumes of milk feeds
  4. No major gut surgery or suspected severe bowel disease
  5. Parent has not chosen to opt out
Answer every question to see your result.

What does participation involve?

Because both methods are already standard practice across NHS hospitals, your baby will not receive any experimental medicine. If included, a computer will place your baby by chance (like flipping a coin) into one of two groups: regular stomach checks or no routine stomach checks. No extra hospital visits, blood tests, or scans are required. The study simply tracks your baby's feeding progress as part of their normal bedside care until they reach full milk feeds, go home, or reach four weeks past their due date (whichever comes first).

Potential risks and benefits

Both feeding methods are already routinely used in UK hospitals, so researchers do not expect any extra medical risks from taking part. Avoiding routine checks might help babies move to full milk feeds more quickly, which could lower the chance of bloodstream infections from feeding drips. Doctors and nurses will continue checking for tummy problems using their normal close monitoring. Parents have the full right to opt their baby out at any point, and choosing to do so will never change or harm the care their baby receives.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Chelsea and Westminster Hospital NHS Foundation Trust
    City only
    London, England
  • East Kent Hospitals University NHS Foundation Trust
    City only
    Canterbury, England
  • Belfast Health and Social Care Trust
    City only
    Belfast, Northern Ireland
  • Bradford Teaching Hospitals NHS Foundation Trust
    City only
    Bradford, England
  • Royal Cornwall Hospitals NHS Trust
    City only
    Truro, England
  • University Hospitals of Derby and Burton NHS Foundation Trust
    Unverified
    Derby, England
  • Medway NHS Foundation Trust
    Unverified
    Gillingham, England
  • Hull University Teaching Hospitals NHS Trust
    Unverified
    Hull, England
  • University Hospitals of Leicester NHS Trust
    Unverified
    Leicester, England
  • Liverpool Women's NHS Foundation Trust
    Unverified
    Liverpool, England
  • Guy's and St Thomas' NHS Foundation Trust
    Unverified
    London, England
  • The Hillingdon Hospitals NHS Foundation Trust
    Unverified
    Uxbridge, England

Common questions

Why was my baby automatically included in this study?

The study uses an 'opt-out' approach because both feeding methods are already standard care in the NHS. This makes research simpler for families during a stressful time and ensures that results represent all types of babies.

Can I choose which feeding group my baby is in?

No. A computer randomly decides which group a baby joins. This ensures the trial is fair and that the results can be trusted.

Will my baby need any extra tests or needles?

No. Taking part does not involve extra blood tests, scans, or hospital appointments. In fact, babies in the group without routine checks may experience less handling and disturbance.

What happens if I decide I do not want my baby to take part?

You can tell your baby's doctor or nurse at any time that you wish to opt out. Your decision will be fully respected, and your baby will continue receiving the best possible care.

Does this trial test any new drugs?

No. The study does not test any new medicines. It only looks at how nurses and doctors check feeding tubes and manage milk feeds.

How to find out more

Elizabeth Nuthall

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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