WithHolding Enteral Feeds Around Blood Transfusion (International)

NCT05213806 · tracked via the Priya Life Science Canada tracker

Sponsor

IWK Health Centre

Phase

Not applicable

Started

2022-01-28

Last updated

2026-04-24

Condition(s) studied

Necrotizing Enterocolitis

Investigational drug(s) / intervention(s)

Withholding feeds around transfusionContinued feeds around transfusion

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

Study 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

Sex

ALL

Min age

—

Max age

30 Weeks

Healthy volunteers

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.

Primary outcome measure(s)

NEC Stage II — From randomization to 40 weeks postmenstrual age
Stage II or greater NEC recorded after the first trial blood transfusion; defined according to the modified Bell staging criteria: based on clinical features and abdominal imaging findings, or on surgical or histological findings of NEC.

Trial sites (40)

Facility	City	Region	Status
IWK Health	Halifax	Nova Scotia	Recruiting
Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)	Norwich	England	Recruiting
The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)	Hillingdon	UK	Recruiting
Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)	London	UK	Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)	London	UK	Recruiting
Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)	London	UK	Recruiting
Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)	Luton	UK	Recruiting
East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)	Ashford	United Kingdom	Recruiting
Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)	Aylesbury	United Kingdom	Recruiting
Barnsley Hospital NHS Foundation Trust	Barnsley	United Kingdom	Recruiting
Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)	Birmingham	United Kingdom	Recruiting
University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)	Birmingham	United Kingdom	Recruiting
Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)	Bradford	United Kingdom	Recruiting
North Bristol NHS Trust (Southmead Hospital)	Bristol	United Kingdom	Recruiting
East and North Essex NHS Foundation Trust - Colchester Hospital	Colchester	United Kingdom	Recruiting
University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)	Coventry	United Kingdom	Recruiting
University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)	Derby	United Kingdom	Recruiting
NHS Tayside (Ninewells Hospital)	Dundee	United Kingdom	Recruiting
Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)	Gillingham	United Kingdom	Recruiting
Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)	Gloucester	United Kingdom	Recruiting
Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)	Halifax	United Kingdom	Recruiting
East and North Essex NHS Foundation Trust - Ipswich Hospital	Ipswich	United Kingdom	Recruiting
Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)	Leeds	United Kingdom	Recruiting
University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)	Leicester	United Kingdom	Recruiting
Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)	Liverpool	United Kingdom	Recruiting
North West London NHS Trust (Northwick Park Hospital)	London	United Kingdom	Recruiting
Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)	Manchester	United Kingdom	Recruiting
Manchester University NHS Foundation Trust (Wythenshawe)	Manchester	United Kingdom	Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)	Newcastle upon Tyne	United Kingdom	Recruiting
Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)	Nottingham	United Kingdom	Recruiting
Oxford University Hospitals NHS FT (John Radcliffe Hospital)	Oxford	United Kingdom	Recruiting
North West Anglia NHS Trust (Peterborough City Hospital)	Peterborough	United Kingdom	Recruiting
Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)	Portsmouth	United Kingdom	Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)	Preston	United Kingdom	Recruiting
The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)	Shrewsbury	United Kingdom	Recruiting
University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)	Southampton	United Kingdom	Recruiting
Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)	Wales	United Kingdom	Recruiting
Walsall Healthcare NHS Trust (Walsall Manor Hospital)	Walsall	United Kingdom	Recruiting
West Hertfordshire Hospitals NHS Trust (Watford General Hospital)	Watford	United Kingdom	Recruiting
Royal Wolverhampton NHS Trust (New Cross Hospital)	Wolverhampton	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05213806 on ClinicalTrials.gov ↗ ← All trials in Canada