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WithHolding Enteral Feeds Around Blood Transfusion (International)

Necrotizing Enterocolitis

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 to 30

Participation 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.

Study Location

IWK Health
IWK Health
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Emily MacLeod

[email protected]
9024706679
Study Sponsored By
IWK Health Centre
Participants Required
More Information
Study ID: NCT05213806