Withholding enteral feeds during blood transfusions in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The WHEAT International trial investigates whether withholding enteral feeds around the time of blood transfusion can reduce the incidence of Necrotizing Enterocolitis (NEC) in very premature infants born at less than 30 weeks gestation. This comparative effectiveness trial will randomize infants from Neonatal Intensive Care Units (NICUs) in Canada and the UK into two groups: one that continues feeding during transfusion and another that withholds feeding. The study aims to provide clarity on the optimal feeding strategy during blood transfusions, addressing a significant gap in current neonatal care practices.

Why it matters

Who can join: the full rules

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.

Where it's running

• IWK Health
  Halifax, Nova Scotia, Canada Recruiting
• Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)
  Norwich, England, United Kingdom Recruiting
• The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)
  Hillingdon, UK, United Kingdom Recruiting
• Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)
  London, UK, United Kingdom Recruiting
• Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)
  London, UK, United Kingdom Recruiting
• Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)
  London, UK, United Kingdom Recruiting

Study contacts

• Principal investigator: Balpreet Singh, MD — IWK Health, Canada
• Study coordinator: Cari-Lee Carnell
• Email: cari-lee.carnell@iwk.nshealth.ca
• Phone: 9024706630

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.