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WithHolding Enteral Feeds Around Blood Transfusion (International)

RecruitingNAAges any - 30 WeeksAllIWK Health Centre
NCT05213806 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.

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📋 Eligibility rules (as published)
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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What it tests

  • Withholding feeds around transfusion
  • Continued feeds around transfusion
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Where

40 sites
IWK Health
Halifax, Canada
Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)
Norwich, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)
Hillingdon, United Kingdom
Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)
London, United Kingdom
Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)
London, United Kingdom
Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)
Luton, United Kingdom
East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)
Ashford, United Kingdom

…and 32 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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