WithHolding Enteral Feeds Around Blood Transfusion (International)
NCT05213806 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4333
Last updated 2026-04-24
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.
Conditions
- Necrotizing Enterocolitis
Interventions
- OTHER
-
Withholding feeds around transfusion
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.
- OTHER
-
Continued feeds around transfusion
Continued enteral feeds
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Imperial College London
collaborator OTHER -
Imperial Clinical Trials Unit (ICTU)
collaborator UNKNOWN -
IWK Health Centre
lead OTHER
Principal Investigators
-
Balpreet Singh, MD · IWK Health, Canada
-
Jon Dorling, MD · Princess Anne Hospital, UK
-
Chris Gale, MD · Imperial College London, UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 30 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-28
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- Canada
- United Kingdom
Study Locations
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