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WithHolding Enteral Feeds Around Blood Transfusion (International)

Launched by IWK HEALTH CENTRE · Jan 17, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Comparative Effectiveness Trial Necrotizing Enterocolitis Premature Infants Blood Transfusion Withholding Enteral Feeds

ClinConnect Summary

The WHEAT International trial is a study aimed at understanding whether stopping feeding very premature infants (those born before 30 weeks) during blood transfusions can help lower the risk of a serious condition called Necrotizing Enterocolitis (NEC). NEC is a condition that affects the intestines and can be quite dangerous for these tiny babies. Researchers will compare two groups of infants in Neonatal Intensive Care Units (NICUs) across Canada and the UK—one group will continue to be fed during transfusions, while the other group will have their feeds paused. This study is important because both methods are currently used, and the research aims to find out which approach might be better for preventing NEC.

To be eligible for the trial, infants must be born very prematurely, specifically before 30 weeks of gestation. Some infants won’t be able to participate, such as those whose parents choose not to take part or those who have specific medical conditions that make feeding unsafe. If your baby qualifies and you decide to participate, you can expect to be part of this important research that could help improve care for future premature infants. The trial is currently looking for participants, and it's a chance to contribute to better understanding in neonatal care.

Gender

ALL

Eligibility criteria

  • 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; buccal colostrum will not be counted as enteral feeding).
  • 3. Infants where enteral feeding is contraindicated in the first 7 days after birth \[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\].
  • 4. Previous episode of NEC or spontaneous intestinal perforation (SIP) prior to first packed cell transfusion.

About Iwk Health Centre

IWK Health Centre is a leading pediatric and women's health facility based in Halifax, Nova Scotia, dedicated to providing high-quality care and advancing medical research. As a prominent clinical trial sponsor, IWK Health Centre collaborates with multidisciplinary teams to conduct innovative research aimed at improving health outcomes for children, youth, and women. The center prioritizes patient-centered approaches in its trials, ensuring that the needs and safety of participants are at the forefront of its research initiatives. With a commitment to excellence and ethical standards, IWK Health Centre contributes significantly to the advancement of medical knowledge and the development of effective therapies.

Locations

Halifax, Nova Scotia, Canada

Patients applied

0 patients applied

Trial Officials

Balpreet Singh, MD

Principal Investigator

IWK Health, Canada

Jon Dorling, MD

Principal Investigator

Princess Anne Hospital, UK

Chris Gale, MD

Principal Investigator

Imperial College London, UK

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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