Actively Recruiting
Led by IWK Health Centre · Updated on 2026-04-24
4333
Participants Needed
40
Research Sites
N/A
Total Duration
I
IWK Health Centre
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
The trial investigates whether stopping or continuing milk feeding around the time of blood transfusion in very premature infants born before 30 weeks gestation affects the risk of developing Necrotizing Enterocolitis (NEC), a serious intestinal disease. NEC can cause severe damage or death in preterm infants, and this study aims to find out which feeding approach during transfusion may reduce this risk. The trial is conducted in neonatal intensive care units across Canada and the UK and compares two standard care methods currently in use. Participants are randomly assigned to one of two groups: one group will stop all enteral feeds for 4 hours before, during, and 4 hours after packed red cell transfusions, with hydration maintained by intravenous nutrition or glucose; the other group will continue feeding as usual throughout the transfusion period. Infants stay in their assigned feeding group until they reach 34 weeks and 6 days gestational age. This approach follows practices identified as acceptable in prior surveys and studies. During the study, infants will be closely monitored for the development of NEC and other health outcomes from randomization until 40 weeks postmenstrual age. Researchers will track serious complications like severe NEC, infections, growth, lung disease, eye problems, brain injury, and hospital stay duration. The study collects detailed information about feeding, infections, nutrition, and clinical status to evaluate the safety and effects of each feeding strategy during transfusion.
CONDITIONS
WithHolding Enteral Feeds Around Blood Transfusion (International)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until 34(+6) weeks gestational age
Participants are randomly assigned to one of two feeding strategies around red cell transfusions: either withholding enteral feeds starting 4 hours before transfusion until 4 hours after, or continuing enteral feeds throughout the transfusion period. Participants remain on their assigned feeding strategy until 34 weeks plus 6 days gestational age.
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
C
Cari-Lee Carnell
T
Tara Hatfield
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Cheryl Battersby, Nick Longford, Sundhiya Mandalia...
https://pubmed.ncbi.nlm.nih.gov/28404014Debora Duro, Leslie A Kalish, Patrick Johnston...
https://pubmed.ncbi.nlm.nih.gov/20447649Susan R Hintz, Douglas E Kendrick, Barbara J Stoll...
https://pubmed.ncbi.nlm.nih.gov/15741374Clare M Rees, Agostino Pierro, Simon Eaton
https://pubmed.ncbi.nlm.nih.gov/16984980Lelia Duley, Seilin Uhm, Sandy Oliver...
https://pubmed.ncbi.nlm.nih.gov/24931684R A Seges, A Kenny, G W Bird...
https://pubmed.ncbi.nlm.nih.gov/6279816Amelie I Stritzke, John Smyth, Anne Synnes...
https://pubmed.ncbi.nlm.nih.gov/22447991Jonathan Blau, Johanna M Calo, Donna Dozor...
https://pubmed.ncbi.nlm.nih.gov/21067771Pradeep Mally, Sergio G Golombek, Ravi Mishra...
https://pubmed.ncbi.nlm.nih.gov/17009195Kellie E Cunningham, Frances C Okolo, Robyn Baker...
https://pubmed.ncbi.nlm.nih.gov/28601308