Actively Recruiting

Phase Not Applicable
Age: 0 - 30Weeks
All Genders
NCT05213806

WithHolding Enteral Feeds Around Blood Transfusion (International)

Led by IWK Health Centre · Updated on 2026-04-24

4333

Participants Needed

40

Research Sites

269 weeks

Total Duration

On this page

Sponsors

I

IWK Health Centre

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

WithHolding Enteral Feeds Around Blood Transfusion (International)

Who Can Participate

Age: 0 - 30Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm birth at less than 30 weeks gestational age
Not Eligible

You will not qualify if you...

  • Parent(s) opt out of trial participation
  • Infant received packed red cell transfusion with concurrent enteral feeds prior to enrollment (except if nil-by-mouth or minimal feeds <15 ml/kg/day during transfusion)
  • Infant is not being fed at the time of randomization (less than 15 ml/kg/day) or feeding is contraindicated (e.g., major congenital gastrointestinal abnormality)
  • Previous episode of Necrotizing Enterocolitis Bell stage 2 or higher or spontaneous intestinal perforation before first study transfusion

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Trial Site Locations

Total: 40 locations

1

IWK Health

Halifax, Nova Scotia, Canada, B3K 6R8

Actively Recruiting

2

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

Norwich, England, United Kingdom

Actively Recruiting

3

The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)

Hillingdon, UK, United Kingdom

Actively Recruiting

4

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

London, UK, United Kingdom

Actively Recruiting

5

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

London, UK, United Kingdom

Actively Recruiting

6

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

London, UK, United Kingdom

Actively Recruiting

7

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

Luton, UK, United Kingdom

Actively Recruiting

8

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

Ashford, United Kingdom

Actively Recruiting

9

Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)

Aylesbury, United Kingdom

Actively Recruiting

10

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Actively Recruiting

11

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

Birmingham, United Kingdom

Actively Recruiting

12

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

Birmingham, United Kingdom

Actively Recruiting

13

Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)

Bradford, United Kingdom

Actively Recruiting

14

North Bristol NHS Trust (Southmead Hospital)

Bristol, United Kingdom

Actively Recruiting

15

East and North Essex NHS Foundation Trust - Colchester Hospital

Colchester, United Kingdom

Actively Recruiting

16

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

Coventry, United Kingdom

Actively Recruiting

17

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

Derby, United Kingdom

Actively Recruiting

18

NHS Tayside (Ninewells Hospital)

Dundee, United Kingdom

Actively Recruiting

19

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

Gillingham, United Kingdom

Actively Recruiting

20

Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)

Gloucester, United Kingdom

Actively Recruiting

21

Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)

Halifax, United Kingdom

Actively Recruiting

22

East and North Essex NHS Foundation Trust - Ipswich Hospital

Ipswich, United Kingdom

Actively Recruiting

23

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

Leeds, United Kingdom

Actively Recruiting

24

University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)

Leicester, United Kingdom

Actively Recruiting

25

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

Liverpool, United Kingdom

Actively Recruiting

26

North West London NHS Trust (Northwick Park Hospital)

London, United Kingdom

Actively Recruiting

27

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

Manchester, United Kingdom

Actively Recruiting

28

Manchester University NHS Foundation Trust (Wythenshawe)

Manchester, United Kingdom

Actively Recruiting

29

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

Newcastle upon Tyne, United Kingdom

Actively Recruiting

30

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

Nottingham, United Kingdom

Actively Recruiting

31

Oxford University Hospitals NHS FT (John Radcliffe Hospital)

Oxford, United Kingdom

Actively Recruiting

32

North West Anglia NHS Trust (Peterborough City Hospital)

Peterborough, United Kingdom

Actively Recruiting

33

Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)

Portsmouth, United Kingdom

Actively Recruiting

34

Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)

Preston, United Kingdom

Actively Recruiting

35

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

Shrewsbury, United Kingdom

Actively Recruiting

36

University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)

Southampton, United Kingdom

Actively Recruiting

37

Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)

Wales, United Kingdom

Actively Recruiting

38

Walsall Healthcare NHS Trust (Walsall Manor Hospital)

Walsall, United Kingdom

Actively Recruiting

39

West Hertfordshire Hospitals NHS Trust (Watford General Hospital)

Watford, United Kingdom

Actively Recruiting

40

Royal Wolverhampton NHS Trust (New Cross Hospital)

Wolverhampton, United Kingdom

Actively Recruiting

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Research Team

C

Cari-Lee Carnell

CONTACT

T

Tara Hatfield

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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