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Withholding enteral feeds during blood transfusions in premature infants

The WHEAT International Trial: WithHolding Enteral Feeds Around Red Cell Transfusion to Prevent Necrotizing Enterocolitis in Preterm Neonates: an International, Multi-centre, Randomized Controlled Trial

NA · IWK Health Centre · NCT05213806

This study is testing if stopping feedings during blood transfusions can help very premature babies avoid a serious gut problem called Necrotizing Enterocolitis.

Quick facts

PhaseNA
Study typeInterventional
Enrollment4333 (estimated)
AgesN/A to 30 Weeks
SexAll
SponsorIWK Health Centre (other)
Locations40 sites (Halifax, Nova Scotia and 39 other locations)
Trial IDNCT05213806 on ClinicalTrials.gov

What this trial studies

The WHEAT International trial investigates whether withholding enteral feeds around the time of blood transfusion can reduce the incidence of Necrotizing Enterocolitis (NEC) in very premature infants born at less than 30 weeks gestation. This comparative effectiveness trial will randomize infants from Neonatal Intensive Care Units (NICUs) in Canada and the UK into two groups: one that continues feeding during transfusion and another that withholds feeding. The study aims to provide clarity on the optimal feeding strategy during blood transfusions, addressing a significant gap in current neonatal care practices.

Who should consider this trial

Good fit: Ideal candidates for this study are very premature infants born at less than 30 weeks gestation.

Not a fit: Patients who have previously experienced NEC or have contraindications for enteral feeding in the first week after birth may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the occurrence of NEC in very premature infants, improving their survival and long-term health outcomes.

How similar studies have performed: While the approach of withholding feeds during transfusions is being explored, there is currently a lack of high-quality evidence, making this study a novel investigation in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Halifax, Nova Scotia and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Necrotizing Enterocolitis, Comparative Effectiveness Trial, Premature Infants, Blood Transfusion, Withholding enteral feeds

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.