RecruitingNot Applicable

WithHolding Enteral Feeds Around Blood Transfusion (International)

Canada, United Kingdom4,333 participantsStarted 2022-01-28

Plain-language 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.

Who can participate

Age range30 Weeks

SexALL

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Exclusion criteria

✕. 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 (\<15ml/kg) 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.

What they're measuring

NEC Stage II

Timeframe: From randomization to 40 weeks postmenstrual age

Trial details

NCT IDNCT05213806

SponsorIWK Health Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Cari-Lee Carnell

9024706630 cari-lee.carnell@iwk.nshealth.ca

View on ClinicalTrials.gov More Necrotizing Enterocolitis trials