NCT05213806 WithHolding Enteral Feeds Around Blood Transfusion (International)
| NCT ID | NCT05213806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IWK Health Centre |
| Condition | Necrotizing Enterocolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,333 participants |
| Start Date | 2022-01-28 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,333 participants in total. It began in 2022-01-28 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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; 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. 3. Infants who are not being fed at the time of randomization (\<15ml/kg) or where enteral feeding is contraindicated \[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\]. 4. Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.
Contact & Investigator
Balpreet Singh, MD
PRINCIPAL INVESTIGATOR
IWK Health, Canada
Frequently Asked Questions
Who can join the NCT05213806 clinical trial?
This trial is open to participants of all sexes, up to 30 Weeks, studying Necrotizing Enterocolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05213806 currently recruiting?
Yes, NCT05213806 is actively recruiting participants. Contact the research team at cari-lee.carnell@iwk.nshealth.ca for enrollment information.
Where is the NCT05213806 trial being conducted?
This trial is being conducted at Halifax, Canada, Norwich, United Kingdom, Hillingdon, United Kingdom, London, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05213806 clinical trial?
NCT05213806 is sponsored by IWK Health Centre. The principal investigator is Balpreet Singh, MD at IWK Health, Canada. The trial plans to enroll 4,333 participants.