The WHEAT International Trial: WithHolding Enteral Feeds Around Red Cell Transfusion to Prevent Necrotizing Enterocolitis in Preterm Neonates: an International, Multi-centre, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 1\. Preterm birth at \<30+0 gestational weeks + days

Locations
Other Locations
Canada
IWK Health
RECRUITING
Halifax
Contact Information
Primary
Emily MacLeod
emily.macleod@iwk.nshealth.ca
9024706679
Backup
Tara Hatfield
tara.hatfield@iwk.nshealth.ca
9024706630
Time Frame
Start Date: 2022-01-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 4333
Treatments
Active_comparator: Withholding feeds around transfusion
All enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the transfusion and until 4 hours post transfusion. During this period, hydration and blood glucose will be maintained according to local practice, commonly by providing parenteral nutrition or intravenous dextrose. Four hours after the red cell transfusion has finished, feeds will be recommenced to how they were being received prior to the decision to transfuse. This duration of withholding feeds will follow the approach used in other trials and observational studies, and identified as the most acceptable in a survey of UK neonatal units. It gives time for milk in the small bowel to transit into the large bowel before the transfusion and for the circulation to stabilize after the transfusion before milk feeds given into the stomach pass through into the small intestine.
Active_comparator: Continuing feeds around transfusion
Enteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse. Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Imperial College London
Leads: IWK Health Centre

This content was sourced from clinicaltrials.gov