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Optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care: a mixed methods consensus process
  1. Chris Gale1,
  2. Jon Dorling2,
  3. Barbara Arch3,
  4. Kerry Woolfall4,
  5. Elizabeth Deja5,
  6. Louise Roper5,
  7. Ashley P Jones6,
  8. Lynne Latten7,
  9. Helen Eccleson3,
  10. Helen Hickey8,
  11. Nazima Pathan9,
  12. Jennifer Preston10,
  13. Anne Beissel11,
  14. Izabela Andrzejewska12,
  15. Frederic Valla13,
  16. Lyvonne Tume14
  1. 1 Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK
  2. 2 Division of Neonatal-Perinatal Medicine, Dalhousie University – Faculty of Medicine, Halifax, Nova Scotia, Canada
  3. 3 Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, Merseyside, UK
  4. 4 Institute of Psychology, University of Liverpool, Liverpool, Merseyside, UK
  5. 5 Department of Health Services Research, University of Liverpool, Liverpool, Merseyside, UK
  6. 6 Medicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK
  7. 7 Department of Nutrition and Dietetics, Alder Hey Children's Hospital, Liverpool, UK
  8. 8 Clinical Trial Research Centre, Medicines for Children Clinical Trials Unit, Liverpool, UK
  9. 9 Department of Paediatrics, University of Cambridge, Cambridge, Cambridgeshire, UK
  10. 10 Women's and Children's Health, University of Liverpool School of Life Sciences, Liverpool, UK
  11. 11 Neonatal Intensive Care Unit, Hôpital Femme Mère Enfant, Lyon-Bron, France
  12. 12 Department of Neonatal Medicine, Chelsea and Westminster Healthcare NHS Trust, London, UK
  13. 13 Service de réanimation pédiatrique, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, Université Claude-Bernard Lyon 1, Lyon, France
  14. 14 Department of Child Health, University of Salford, Salford, Greater Manchester, UK
  1. Correspondence to Dr Chris Gale, Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London SW7 2AZ, UK; christopher.gale{at}


Background Routine measurement of gastric residual volume to guide feeding is widespread in neonatal units but not supported by high-quality evidence. Outcome selection is critical to trial design.

Objective To determine optimal outcome measures for a trial of not routinely measuring gastric residual volume in neonatal care.

Design A focused literature review, parent interviews, modified two-round Delphi survey and stakeholder consensus meeting.

Participants Sixty-one neonatal healthcare professionals participated in an eDelphi survey; 17 parents were interviewed. 19 parents and neonatal healthcare professionals took part in the consensus meeting.

Results Literature review generated 14 outcomes, and parent interviews contributed eight additional outcomes; these 22 outcomes were then ranked by 74 healthcare professionals in the first Delphi round where four further outcomes were proposed; 26 outcomes were ranked in the second round by 61 healthcare professionals. Five outcomes were categorised as ‘consensus in’, and no outcomes were voted ‘consensus out’. ‘No consensus’ outcomes were discussed and voted on in a face-to-face meeting by 19 participants, where four were voted ‘consensus in’. The final nine consensus outcomes were: mortality, necrotising enterocolitis, time to full enteral feeds, duration of parenteral nutrition, time feeds stopped per 24 hours, healthcare-associated infection; catheter-associated bloodstream infection, change in weight between birth and neonatal discharge and pneumonia due to milk aspiration.

Conclusions and relevance We have identified outcomes for a trial of no routine measurement of gastric residual volume to guide feeding in neonatal care. This outcome set will ensure outcomes are important to healthcare professionals and parents.

  • neonatology
  • qualitative research
  • data collection
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  • Twitter @DrCGale, @louise22roper

  • Correction notice The affiliation for Lynne Latton has been updated.

  • Contributors LT, CG and JD equally contributed to the conception and design of the research; HH, KW, ED, LR, AB, FV and BA contributed to the design of the research; HE, JP, IA, NP, LL, BA and ED contributed to the acquisition and analysis of the data; ED and LR conducted qualitative interviews; ED, BA, APJ, LT, CG and JD contributed to the interpretation of the data; and CG, BA and LT drafted the manuscript.

  • Funding This study was funded by the NIHR HTA ref 16/94/02 Department of Health and Social Care disclaimer. This study is part of a larger funded NIHR Feasibility study. This study was preregistered ISRCTN 42110505.

  • Competing interests CG reports grants from Medical Research Council and the NIHR during the conduct of the study; grants from NIHR, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study, and the personal fee was to support attendance at an educational meeting. CG is vice-chair of the NIHR Research for Patient Benefit London Regional Assessment Panel and has sat on the panel since 2016. JD reports grants from NIHR, during the conduct of the study for the study; grants from NIHR, and grants from Nutrinia, outside the submitted work. The grant from Nutrinia in 2018 was for part of his salary to work as an expert advisor on a trial. JD was a member of the NIHR HTA General Board (from 2017 to 2018) and the NIHR HTA Maternity, Newborn and Child Health Panel (from 2013 to 2018). FV reports personal fees from BAXTER, personal fees from NUTRICIA, outside the submitted work. LT is an NIHR HTA panel member.

  • Patient consent for publication Not required.

  • Ethics approval University of the West of England, April 2018 (REF HAS.18.04.144).

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

  • Data availability statement Data are available on reasonable request. Please contact the authors for data requests.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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