Status:
RECRUITING
WithHolding Enteral Feeds Around Blood Transfusion (International)
Lead Sponsor:
IWK Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Imperial College London
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief 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 t...
Detailed Description
BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating disease that affects mostly the intestine of premature infants. The wall of the intestine is invaded by bacteria, which cause local infecti...
Eligibility Criteria
Inclusion
- 1\. Preterm birth at \<30+0 gestational weeks + days
Exclusion
- 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.
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
4333 Patients enrolled
Trial Details
Trial ID
NCT05213806
Start Date
January 28 2022
End Date
March 31 2027
Last Update
November 24 2025
Active Locations (1)
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1
IWK Health
Halifax, Nova Scotia, Canada, B3K 6R8