RecruitingNot ApplicableNCT05213806

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

Sponsor

IWK Health Centre

Enrollment

4,333 participants

Start Date

Jan 28, 2022

Study Type

INTERVENTIONAL

Conditions

Necrotizing Enterocolitis

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

Max Age: 30 Weeks

Plain Language Summary

Simplified for easier understanding

This study is looking at whether it is safer to pause or continue feeding premature babies through a feeding tube during red blood cell transfusions. Very premature babies sometimes develop a dangerous bowel condition (NEC) around the time of transfusions, and researchers want to know if withholding feeds during transfusion reduces this risk. You may be eligible if... - Your baby was born before 30 weeks of gestational age You may NOT be eligible if... - Your parents have opted out of participation - Your baby has already received a blood transfusion while on active feeding - Your baby is not currently being fed or feeding is medically contraindicated - Your baby has had a previous episode of NEC (stage 2 or higher) or spontaneous intestinal perforation before their first study transfusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERWithholding 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.

OTHERContinued feeds around transfusion

Continued enteral feeds

Locations(40)

IWK Health

Halifax, Nova Scotia, Canada

Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)

Norwich, England, United Kingdom

The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)

Hillingdon, UK, United Kingdom

Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)

London, UK, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)

London, UK, United Kingdom

Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)

London, UK, United Kingdom

Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)

Luton, UK, United Kingdom

East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)

Ashford, United Kingdom

Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)

Aylesbury, United Kingdom

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)

Birmingham, United Kingdom

University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)

Birmingham, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)

Bradford, United Kingdom

North Bristol NHS Trust (Southmead Hospital)

Bristol, United Kingdom

East and North Essex NHS Foundation Trust - Colchester Hospital

Colchester, United Kingdom

University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)

Coventry, United Kingdom

University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)

Derby, United Kingdom

NHS Tayside (Ninewells Hospital)

Dundee, United Kingdom

Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)

Gillingham, United Kingdom

Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)

Gloucester, United Kingdom

Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)

Halifax, United Kingdom

East and North Essex NHS Foundation Trust - Ipswich Hospital

Ipswich, United Kingdom

Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)

Leeds, United Kingdom

University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)

Leicester, United Kingdom

Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)

Liverpool, United Kingdom

North West London NHS Trust (Northwick Park Hospital)

London, United Kingdom

Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)

Manchester, United Kingdom

Manchester University NHS Foundation Trust (Wythenshawe)

Manchester, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)

Newcastle upon Tyne, United Kingdom

Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)

Nottingham, United Kingdom

Oxford University Hospitals NHS FT (John Radcliffe Hospital)

Oxford, United Kingdom

North West Anglia NHS Trust (Peterborough City Hospital)

Peterborough, United Kingdom

Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)

Portsmouth, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)

Preston, United Kingdom

The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)

Shrewsbury, United Kingdom

University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)

Southampton, United Kingdom

Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)

Wales, United Kingdom

Walsall Healthcare NHS Trust (Walsall Manor Hospital)

Walsall, United Kingdom

West Hertfordshire Hospitals NHS Trust (Watford General Hospital)

Watford, United Kingdom

Royal Wolverhampton NHS Trust (New Cross Hospital)

Wolverhampton, United Kingdom

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