WithHolding Enteral Feeds Around Blood Transfusion (International)
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
IWK Health Centre
4,333 participants
Jan 28, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- \. Preterm birth at \<30+0 gestational weeks + days
Exclusion Criteria4
- Parent(s) opt-out of trial participation.
- 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.
- Infants who are not being fed at the time of randomization or where enteral feeding is contraindicated \[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\].
- Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.
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Interventions
Withholding enteral feeds for preterm infants (\<30 weeks) around the time of blood transfusions to determine if any impact on the development and/or severity of Necrotizing Enterocolitis.
Continued enteral feeds
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05213806