BibTex format
@article{Gale:2019:10.1136/bmjopen-2019-033543,
author = {Gale, C and Modi, N and Jawad, S and Culshaw, L and Dorling, J and Bowler, U and Forster, A and King, A and McLeish, J and Linsell, L and Turner, MA and Robberts, H and Stanbury, K and van, Staa T and Juszczak, E},
doi = {10.1136/bmjopen-2019-033543},
journal = {BMJ Open},
pages = {1--7},
title = {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.},
url = {http://dx.doi.org/10.1136/bmjopen-2019-033543},
volume = {9},
year = {2019}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - 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 infor
AU - Gale,C
AU - Modi,N
AU - Jawad,S
AU - Culshaw,L
AU - Dorling,J
AU - Bowler,U
AU - Forster,A
AU - King,A
AU - McLeish,J
AU - Linsell,L
AU - Turner,MA
AU - Robberts,H
AU - Stanbury,K
AU - van,Staa T
AU - Juszczak,E
DO - 10.1136/bmjopen-2019-033543
EP - 7
PY - 2019///
SN - 2044-6055
SP - 1
TI - 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.
T2 - BMJ Open
UR - http://dx.doi.org/10.1136/bmjopen-2019-033543
UR - https://www.ncbi.nlm.nih.gov/pubmed/31542771
UR - https://bmjopen.bmj.com/content/9/9/e033543
UR - http://hdl.handle.net/10044/1/73188
VL - 9
ER -
