TY - JOUR
T1 - Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children
T2 - The gastric feasibility study
AU - Tume, Lyvonne N.
AU - Woolfall, Kerry
AU - Arch, Barbara
AU - Roper, Louise
AU - Deja, Elizabeth
AU - Jones, Ashley P.
AU - Latten, Lynne
AU - Pathan, Nazima
AU - Eccleson, Helen
AU - Hickey, Helen
AU - Parslow, Roger
AU - Preston, Jennifer
AU - Beissel, Anne
AU - Andrzejewska, Izabela
AU - Gale, Chris
AU - Valla, Frederic V.
AU - Dorling, Jon
N1 - Funding Information:
The research reported in this issue of the journal was funded by the HTA programme as project number 16/94/02. The contractual start date was in April 2018. The draft report began editorial review in October 2019 and was accepted for publication in January 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Funding Information:
Declared competing interests of authors: Lyvonne N Tume was a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) panel member during the conduct of the study and is the deputy chairperson of the HTA Prioritisation Committee. Chris Gale reports grants from the Medical Research Council during the conduct of the study; and grants from the NIHR (research grant and fellowship for a Doctor of Philosophy student), the Mason Medical Research Foundation (London, UK), Rosetrees Trust (Edgware, UK) and from the Canadian Institute for Health Research (Ottawa, ON, Canada), outside the submitted work. Chris Gale also reports grants and personal fees from Chiesi Pharmaceuticals (Parma, Italy), outside the submitted work (the grant is for a research study and the personal fee was to support attendance at an educational meeting). Chris Gale is vice-chairperson of the NIHR Research for Patient Benefit London Regional Assessment Panel (2016–present). Frederic V Valla reports personal fees from Baxter International (Deerfield, IL, USA) and personal fees from Nutricia (Zoetermeer, the Netherlands), outside the submitted work. Jon Dorling reports grants from the NIHR and from Nutrinia (Nazareth, Israel), 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). Jon Dorling was a member of the NIHR HTA General Board (2017–18) and the NIHR HTA Maternity, Neonatal and Child Health Panel (2013–18).
Funding Information:
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 23. See the NIHR Journals Library website for further project information.
Publisher Copyright:
© NIHR Journals Library. All rights reserved.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - Background: The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it. Objective: To answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units? Design: A mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals’ opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study. Participants and setting: Parents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units. Results: Baseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flow chart and education package. The trial design survey and e-Delphi study gained consensus on 12 paediatric intensive care unit and nine neonatal unit outcome measures, and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed that trials were feasible in both settings in terms of patient numbers. Of 16,222 children who met the inclusion criteria in paediatric intensive care units, 12,629 stayed for > 3 days. In neonatal units, 15,375 neonates < 32 weeks of age met the inclusion criteria. Finally, the two consensus meetings demonstrated ‘buy-in’ from the wider UK neonatal communities and paediatric intensive care units, and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study. Conclusions and future work: Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined as a result of differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties. Trial registration: Current Controlled Trials ISRCTN42110505.
AB - Background: The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it. Objective: To answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units? Design: A mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals’ opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study. Participants and setting: Parents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units. Results: Baseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flow chart and education package. The trial design survey and e-Delphi study gained consensus on 12 paediatric intensive care unit and nine neonatal unit outcome measures, and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed that trials were feasible in both settings in terms of patient numbers. Of 16,222 children who met the inclusion criteria in paediatric intensive care units, 12,629 stayed for > 3 days. In neonatal units, 15,375 neonates < 32 weeks of age met the inclusion criteria. Finally, the two consensus meetings demonstrated ‘buy-in’ from the wider UK neonatal communities and paediatric intensive care units, and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study. Conclusions and future work: Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined as a result of differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties. Trial registration: Current Controlled Trials ISRCTN42110505.
UR - http://www.scopus.com/inward/record.url?scp=85085539761&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85085539761&partnerID=8YFLogxK
UR - https://research.edgehill.ac.uk/en/publications/bb0d3449-f5cc-4345-ba36-691e6b595bdf
U2 - 10.3310/hta24230
DO - 10.3310/hta24230
M3 - Article (journal)
C2 - 32458797
AN - SCOPUS:85085539761
SN - 1366-5278
VL - 24
SP - 1
EP - 120
JO - Health Technology Assessment
JF - Health Technology Assessment
IS - 23
ER -
