Necrotizing Enterocolitis Clinical Trials

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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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 1\. Preterm birth at \<30+0 gestational weeks + days

Locations
Other Locations
Canada
IWK Health
RECRUITING
Halifax
United Kingdom
East Kent University Hospitals NHS Foundation Trust (William Harvey Hospital)
RECRUITING
Ashford
Buckinghamshire Healthcare NHS Trust (Stoke Mandeville Hospital)
RECRUITING
Aylesbury
Barnsley Hospital NHS Foundation Trust
RECRUITING
Barnsley
Birmingham Women's and Children's NHS Foundation Trust (Birmingham Women's Hospital NICU)
RECRUITING
Birmingham
University Hospitals Birmingham NHS Trust (2 Hospitals: Heartland's Hospital & Good Hope Hospital)
RECRUITING
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust (Bradford Royal Infirmary)
RECRUITING
Bradford
North Bristol NHS Trust (Southmead Hospital)
RECRUITING
Bristol
East and North Essex NHS Foundation Trust - Colchester Hospital
RECRUITING
Colchester
University Hospital Coventry & Warwickshire NHS Trust (University Hospital Coventry)
RECRUITING
Coventry
University Hospitals of Derby and Burton NHS Trust (Royal Derby Hospital)
RECRUITING
Derby
NHS Tayside (Ninewells Hospital)
RECRUITING
Dundee
Medway Hospital NHS Foundation Trust (Oliver Fisher Neonatal Unit, Medway Maritime Hospital)
RECRUITING
Gillingham
Gloucestershire Hospitals NHS Foundation Trust (Gloucestershire Royal Hospital)
RECRUITING
Gloucester
Calderdale & Huddersfield NHS Foundation Trust (Calderdale Royal Hospital)
RECRUITING
Halifax
The Hillingdon Hospitals NHS Foundation Trust (Hillingdon Hospital)
RECRUITING
Hillingdon
East and North Essex NHS Foundation Trust - Ipswich Hospital
RECRUITING
Ipswich
Leeds Teaching Hospitals NHS Trust (Leeds General Infirmary & St James' University Hospital)
RECRUITING
Leeds
University Hospitals of Leicester NHS Trust (Leicester Royal Infirmary)
RECRUITING
Leicester
Liverpool Women's Hospital NHS Foundation Trust (Liverpool Women's Hospital)
RECRUITING
Liverpool
Barts Health NHS Trust (3 Hospitals: Royal London Hospital, Whipps Cross Hospital, Newham General Hospital)
RECRUITING
London
Chelsea and Westminster Hospital NHS Foundation Trust (Chelsea and Westminster Hospital)
RECRUITING
London
Imperial College Healthcare NHS Trust (2 Hospitals: St Mary's Hospital & Queen Charlotte's and Chelsea Hospital)
RECRUITING
London
North West London NHS Trust (Northwick Park Hospital)
RECRUITING
London
Bedfordshire Hospitals NHS Foundation Trust (Luton & Dunstable University Hospital)
RECRUITING
Luton
Manchester University NHS Foundation Trust (2 Hospitals: St Mary's Hospital - Oxford Road, North Manchester General)
RECRUITING
Manchester
Manchester University NHS Foundation Trust (Wythenshawe)
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (Royal Victoria Infirmary)
RECRUITING
Newcastle Upon Tyne
Norfolk & Norwich University Hospitals NHS Foundation Trust (Norfolk & Norwich University Hospital)
RECRUITING
Norwich
Nottingham University Hospitals NHS Trust (2 Hospitals: City Hospital, Queen's Medical Centre)
RECRUITING
Nottingham
Oxford University Hospitals NHS FT (John Radcliffe Hospital)
RECRUITING
Oxford
North West Anglia NHS Trust (Peterborough City Hospital)
RECRUITING
Peterborough
Portsmouth University Hospitals NHS Trust (Queen Alexandra Hospital)
RECRUITING
Portsmouth
Lancashire Teaching Hospitals NHS Foundation Trust (Royal Preston Hospital)
RECRUITING
Preston
The Shrewsbury & Telford Hospitals NHS Trust (Royal Shrewsbury Hospital)
RECRUITING
Shrewsbury
University Hospital Southampton NHS Foundation Trust (Southampton General Hospital)
RECRUITING
Southampton
Betsi Cadwaladr University Health Board (Glan Cwyd Hospital)
RECRUITING
Wales
Walsall Healthcare NHS Trust (Walsall Manor Hospital)
RECRUITING
Walsall
West Hertfordshire Hospitals NHS Trust (Watford General Hospital)
RECRUITING
Watford
Royal Wolverhampton NHS Trust (New Cross Hospital)
RECRUITING
Wolverhampton
Contact Information
Primary
Cari-Lee Carnell
cari-lee.carnell@iwk.nshealth.ca
9024706630
Backup
Tara Hatfield
tara.hatfield@iwk.nshealth.ca
9024706630
Time Frame
Start Date: 2022-01-28
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 4333
Treatments
Active_comparator: Withholding feeds around transfusion
All enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the transfusion and until 4 hours post transfusion. During this period, hydration and blood glucose will be maintained according to local practice, commonly by providing parenteral nutrition or intravenous dextrose. Four hours after the red cell transfusion has finished, feeds will be recommenced to how they were being received prior to the decision to transfuse. This duration of withholding feeds will follow the approach used in other trials and observational studies, and identified as the most acceptable in a survey of UK neonatal units. It gives time for milk in the small bowel to transit into the large bowel before the transfusion and for the circulation to stabilize after the transfusion before milk feeds given into the stomach pass through into the small intestine.
Active_comparator: Continuing feeds around transfusion
Enteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse. Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Imperial College London, Imperial Clinical Trials Unit (ICTU)
Leads: IWK Health Centre

This content was sourced from clinicaltrials.gov