Simple feeding pause could save preemie lives
NCT ID NCT05213806
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This large international trial tests whether temporarily stopping milk feeds around the time of a blood transfusion can prevent necrotizing enterocolitis (NEC), a severe gut infection, in very premature babies (born before 30 weeks). Over 4,000 infants in Canada and the UK will be randomly assigned to either have feeds paused or continued during transfusions. The goal is to see which approach reduces the risk of NEC and death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- withholding enteral feeds around blood transfusion
- What this could lead to
- If it works, this simple change in care could prevent a life-threatening gut disease in thousands of premature babies each year.
- What could go wrong
- This is a large trial, but the approach is already used in some hospitals, so the difference between groups may be small. Also, withholding feeds might have its own risks for fragile infants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 4,333 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 30 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\. Preterm birth at \<30+0 gestational weeks + days Exclusion Criteria: 1. Parent(s) opt-out of trial participation. 2. Packed red cell transfusion with concurrent enteral feeds prior to enrolment. (Infants who have received a packed red cell transfusion while nil-by-mouth are eligible; or minimal enteral nutrition (\<15 ml/kg/day feeds) at the time of transfusion; defined as before, during and for at least 4 hours after transfusion, are eligible. 3. Infants who are not being fed at the time of randomization (\<15ml/kg) or where enteral feeding is contraindicated \[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\]. 4. Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
40 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Barnsley Hospital NHS Foundation Trust
RECRUITINGBarnsley, United Kingdom
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Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)
RECRUITINGLondon, UK, United Kingdom
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Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)
RECRUITINGLuton, UK, United Kingdom
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Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)
RECRUITINGWales, United Kingdom
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Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)
RECRUITINGBirmingham, United Kingdom
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Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)
RECRUITINGBradford, United Kingdom
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Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)
RECRUITINGAylesbury, United Kingdom
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Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)
RECRUITINGHalifax, United Kingdom
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Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)
RECRUITINGLondon, UK, United Kingdom
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East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)
RECRUITINGAshford, United Kingdom
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East and North Essex NHS Foundation Trust - Colchester Hospital
RECRUITINGColchester, United Kingdom
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East and North Essex NHS Foundation Trust - Ipswich Hospital
RECRUITINGIpswich, United Kingdom
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Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)
RECRUITINGGloucester, United Kingdom
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IWK Health
RECRUITINGHalifax, Nova Scotia, B3K 6R8, Canada
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Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)
RECRUITINGLondon, UK, United Kingdom
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Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)
RECRUITINGPreston, United Kingdom
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Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)
RECRUITINGLeeds, United Kingdom
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Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)
RECRUITINGLiverpool, United Kingdom
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Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)
RECRUITINGManchester, United Kingdom
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Manchester University NHS Foundation Trust (Wythenshawe)
RECRUITINGManchester, United Kingdom
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Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)
RECRUITINGGillingham, United Kingdom
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NHS Tayside (Ninewells Hospital)
RECRUITINGDundee, United Kingdom
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Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)
RECRUITINGNorwich, England, United Kingdom
Contact Email: •••••@•••••
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North Bristol NHS Trust (Southmead Hospital)
RECRUITINGBristol, United Kingdom
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North West Anglia NHS Trust (Peterborough City Hospital)
RECRUITINGPeterborough, United Kingdom
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North West London NHS Trust (Northwick Park Hospital)
RECRUITINGLondon, United Kingdom
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Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)
RECRUITINGNottingham, United Kingdom
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Oxford University Hospitals NHS FT (John Radcliffe Hospital)
RECRUITINGOxford, United Kingdom
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Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)
RECRUITINGPortsmouth, United Kingdom
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Royal Wolverhampton NHS Trust (New Cross Hospital)
RECRUITINGWolverhampton, United Kingdom
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The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)
RECRUITINGHillingdon, UK, United Kingdom
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The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)
RECRUITINGNewcastle upon Tyne, United Kingdom
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The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)
RECRUITINGShrewsbury, United Kingdom
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University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)
RECRUITINGCoventry, United Kingdom
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University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)
RECRUITINGSouthampton, United Kingdom
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University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)
RECRUITINGBirmingham, United Kingdom
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University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)
RECRUITINGDerby, United Kingdom
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University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)
RECRUITINGLeicester, United Kingdom
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Walsall Healthcare NHS Trust (Walsall Manor Hospital)
RECRUITINGWalsall, United Kingdom
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West Hertfordshire Hospitals NHS Trust (Watford General Hospital)
RECRUITINGWatford, United Kingdom
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Other studies related to the condition(s) this trial covers.
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