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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

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Paediatrics
Protocol
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
  1. Chris Gale1,
  2. Neena Modi1,
  3. Sena Jawad1,
  4. Lucy Culshaw2,
  5. Jon Dorling3,
  6. Ursula Bowler4,
  7. Amanda Forster5,
  8. Andy King4,
  9. Jenny McLeish6,
  10. Louise Linsell4,
  11. Mark A Turner7,
  12. Helen Robberts8,
  13. Kayleigh Stanbury4,
  14. Tjeerd van Staa9,
  15. Ed Juszczak4
  1. 1 Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK
  2. 2 Bliss – The National Charity for the Newborn, London, UK
  3. 3 Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, IWK Health Centre, Halifax, Nova Scotia, Canada
  4. 4 Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK
  5. 5 Neonatal Unit, James Cook University Hospital, Middlesbrough, UK
  6. 6 Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK
  7. 7 Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  8. 8 Parent of Preterm Twins, Bliss – The National Charity for the Newborn, London, UK
  9. 9 Centre for Health Informatics, Division of Informatics, Imaging and Data Science, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
  1. Correspondence to Dr Chris Gale; christopher.gale{at}imperial.ac.uk

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.

  • randomised controlled trial
  • preterm infant
  • blood bank & transfusion medicine
  • neonatology
  • NNRD
  • electronic patient records

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-033543

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    Footnotes

    • Contributors CG, NM, JD, AF, MAT, HR, TvS and EJ conceived the study. CG, NM, SJ, LC, JD, UB, AF, AK, JM, LL, MAT, HR, KS, TvS and EJ contributed to the planning, conduct and reporting of the study, and writing this manuscript. All authors read and approved the final manuscript. HR is a parent of a preterm twins and LC is a representative of Bliss the charity for babies born premature or sick.

    • Funding The trial is funded through a United Kingdom Medical Research Council (MRC) Clinician Scientist Fellowship awarded to CG.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval Research Ethics Committee approval was granted on 6 July 2018 by London—Bloomsbury Research Ethics Committee (18/LO/0900).

    • Provenance and peer review Not commissioned; externally peer reviewed.