NCT05213806From ClinicalTrials.govRecruiting

WithHolding Enteral Feeds Around Blood Transfusion (International)

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

Necrotizing Enterocolitis

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: IWK Health Centre
Enrolment target: 4,333
Started: 28 January 2022
Main results due: 31 March 2027
Study sites: 40
Registry updated: 29 September 2026

Can you take part?

Up to 30 weeks.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(40)

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
Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)
Luton, UK, United Kingdom
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

Showing 40 of 40 sites. 40 of the 40 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05213806. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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