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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.
Afiliação
  • Gale C; Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK christopher.gale@imperial.ac.uk.
  • Modi N; Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK.
  • Jawad S; Neonatal Medicine, School of Public Health, Chelsea and Westminster campus, Imperial College London, London, UK.
  • Culshaw L; Bliss - The National Charity for the Newborn, London, UK.
  • Dorling J; Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, IWK Health Centre, Halifax, Nova Scotia, Canada.
  • Bowler U; Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
  • Forster A; Neonatal Unit, James Cook University Hospital, Middlesbrough, UK.
  • King A; Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
  • McLeish J; Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
  • Linsell L; Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
  • Turner MA; Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
  • Robberts H; Parent of Preterm Twins, Bliss - The National Charity for the Newborn, London, UK.
  • Stanbury K; Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
  • van Staa T; 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.
  • Juszczak E; Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, National Perinatal Epidemiology Unit, Oxford, UK.
BMJ Open ; 9(9): e033543, 2019 09 20.
Article em En | MEDLINE | ID: mdl-31542771
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Nutrição Enteral / Transfusão de Eritrócitos / Enterocolite Necrosante Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Limite: Humans / Newborn Idioma: En Revista: BMJ Open Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Reino Unido

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Nutrição Enteral / Transfusão de Eritrócitos / Enterocolite Necrosante Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Qualitative_research Limite: Humans / Newborn Idioma: En Revista: BMJ Open Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Reino Unido