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The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial

Gale, Chris; Modi, Neena; Jawad, Sena; Culshaw, Lucy; Dorling, Jon; Bowler, Ursula; Forster, Amanda; King, Andy; McLeish, Jenny; Linsell, Louise; Turner, Mark A.; Robberts, Helen; Stanbury, Kayleigh; Van Staa, Tjeerd; Juszczak, Ed

The WHEAT pilot trial - WithHolding Enteral feeds around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: A multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial Thumbnail


Authors

Chris Gale

Neena Modi

Sena Jawad

Lucy Culshaw

Jon Dorling

Ursula Bowler

Amanda Forster

Andy King

Jenny McLeish

Louise Linsell

Mark A. Turner

Helen Robberts

Kayleigh Stanbury

Tjeerd Van Staa



Abstract

Introduction Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment. Methods and analysis We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at <30+0 gestational weeks+days. Primary feasibility outcomes will be rate of recruitment, opt-out, retention, compliance, data completeness and data accuracy; clinical outcomes will include mortality and NEC. The trial will recruit in two neonatal networks in England for 9 months. Data collection will continue until all infants have reached 40+0 corrected gestational weeks or neonatal discharge. Participant identification and recruitment, randomisation and all trial data collection will be embedded within existing neonatal EPR systems (BadgerNet and BadgerEPR); outcome data will be extracted from routinely recorded data held in the National Neonatal Research Database. Ethics and dissemination This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will inform future EPR-embedded and data-enabled trials and will be disseminated through conferences, publications and parent-centred information. Trial registration number ISRCTN registry ISRCTN62501859; Pre-results.

Journal Article Type Article
Acceptance Date Sep 5, 2019
Online Publication Date Sep 20, 2019
Publication Date Sep 1, 2019
Deposit Date Jan 29, 2024
Publicly Available Date Jan 31, 2024
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 9
Article Number e033543
DOI https://doi.org/10.1136/bmjopen-2019-033543
Public URL https://nottingham-repository.worktribe.com/output/17088768