Recruiting

Observational Study

Sponsor:

IWK Health Centre

Code:

NCT05213806

Conditions

Necrotizing Enterocolitis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Withholding feeds around transfusion

Continued feeds around transfusion

Study Details

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.

Conditions

Necrotizing Enterocolitis

Study ID

NCT05213806

Start date

Jan 28, 2022

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4333 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Withholding feeds around transfusion

Withholding enteral feeds for preterm infants (<30 weeks) around the time of blood transfusions to determine if any impact on the development and/or severity of Necrotizing Enterocolitis.

Continued feeds around transfusion

Continued enteral feeds

Primary outcome measure

  • NEC Stage II [ Time Frame: From randomization to 40 weeks postmenstrual age ]

Central Contacts and Locations

Central contacts

Cari-Lee Carnell

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

Tara Hatfield

9024706630tara.hatfield@iwk.nshealth.ca

Locations

IWK Health

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Cari-Lee Carnell

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

Principal Investigator:

Balpreet Singh, MD

More Information

Sponsor

IWK Health Centre

Last update posted

Apr 24, 2026

Last verified

Nov, 2025

Keywords

  • Comparative Effectiveness Trial
  • Necrotizing Enterocolitis
  • Premature Infants
  • Blood Transfusion
  • Withholding enteral feeds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2026-04-24.