WithHolding Enteral Feeds Around Blood Transfusion (International)

NCT05213806 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4333

Last updated 2026-04-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05213806 on ClinicalTrials.gov