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Simple feeding pause could save preemie lives

NCT ID NCT05213806

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 4,333 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

Up to 30 weeks

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Barnsley Hospital NHS Foundation Trust

    RECRUITING

    Barnsley, United Kingdom

  • Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)

    RECRUITING

    London, UK, United Kingdom

  • Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)

    RECRUITING

    Luton, UK, United Kingdom

  • Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)

    RECRUITING

    Wales, United Kingdom

  • Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)

    RECRUITING

    Birmingham, United Kingdom

  • Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)

    RECRUITING

    Bradford, United Kingdom

  • Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)

    RECRUITING

    Aylesbury, United Kingdom

  • Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)

    RECRUITING

    Halifax, United Kingdom

  • Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)

    RECRUITING

    London, UK, United Kingdom

  • East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)

    RECRUITING

    Ashford, United Kingdom

  • East and North Essex NHS Foundation Trust - Colchester Hospital

    RECRUITING

    Colchester, United Kingdom

  • East and North Essex NHS Foundation Trust - Ipswich Hospital

    RECRUITING

    Ipswich, United Kingdom

  • Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)

    RECRUITING

    Gloucester, United Kingdom

  • IWK Health

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)

    RECRUITING

    London, UK, United Kingdom

  • Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)

    RECRUITING

    Preston, United Kingdom

  • Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)

    RECRUITING

    Leeds, United Kingdom

  • Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)

    RECRUITING

    Liverpool, United Kingdom

  • Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)

    RECRUITING

    Manchester, United Kingdom

  • Manchester University NHS Foundation Trust (Wythenshawe)

    RECRUITING

    Manchester, United Kingdom

  • Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)

    RECRUITING

    Gillingham, United Kingdom

  • NHS Tayside (Ninewells Hospital)

    RECRUITING

    Dundee, United Kingdom

  • Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)

    RECRUITING

    Norwich, England, United Kingdom

    Contact Email: •••••@•••••

  • North Bristol NHS Trust (Southmead Hospital)

    RECRUITING

    Bristol, United Kingdom

  • North West Anglia NHS Trust (Peterborough City Hospital)

    RECRUITING

    Peterborough, United Kingdom

  • North West London NHS Trust (Northwick Park Hospital)

    RECRUITING

    London, United Kingdom

  • Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)

    RECRUITING

    Nottingham, United Kingdom

  • Oxford University Hospitals NHS FT (John Radcliffe Hospital)

    RECRUITING

    Oxford, United Kingdom

  • Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)

    RECRUITING

    Portsmouth, United Kingdom

  • Royal Wolverhampton NHS Trust (New Cross Hospital)

    RECRUITING

    Wolverhampton, United Kingdom

  • The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)

    RECRUITING

    Hillingdon, UK, United Kingdom

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)

    RECRUITING

    Shrewsbury, United Kingdom

  • University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)

    RECRUITING

    Coventry, United Kingdom

  • University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)

    RECRUITING

    Southampton, United Kingdom

  • University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)

    RECRUITING

    Birmingham, United Kingdom

  • University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)

    RECRUITING

    Derby, United Kingdom

  • University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)

    RECRUITING

    Leicester, United Kingdom

  • Walsall Healthcare NHS Trust (Walsall Manor Hospital)

    RECRUITING

    Walsall, United Kingdom

  • West Hertfordshire Hospitals NHS Trust (Watford General Hospital)

    RECRUITING

    Watford, United Kingdom

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