WithHolding Enteral Feeds Around Blood Transfusion (International)
ConditionNecrotizing Enterocolitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorIWK Health Centre
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Withholding feeds around transfusion
- Continued feeds around transfusion
Treatment groups
4,333 Participants
are divided into 2 treatment groupsSponsors and collaborators
IWK Health Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Imperial College London
Collaborator
Imperial Clinical Trials Unit (ICTU)
Collaborator
Source ClinicalTrials.gov