Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial):  study protocol for a multi-centre, unblinded, randomised, controlled trial

Elizabeth Nuthall; Amy Rodriquez; Iza Andrzejewksa; Zainab Aslam; Cheryl Battersby; Catherine Beesley; Christina Cole; Helen Campbell; Kim Dalziel; Jon Dorling; Alan Downs; Peter G. Davis; Zoe Daskalopoulou; Amanda Forster; Michaela Graham-Travis; Nigel J. Hall; Marie Hubbard; Madeleine Hurd; Pollyanna Hardy; Rod Hunt; Ann Kennedy; Andrew King; Louise Linsell; Brett J. Manley; David Murray; Tracy K. Mitchell; Heather O’Connor; Shalini Ojha; Charles C. Roehr; Oliver Rivero-Arias; The neoGASTRIC collaborative group; et al

doi:10.1186/s13063-025-09403-7

Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial

Elizabeth Nuthall, Amy Rodriquez, Iza Andrzejewksa, Zainab Aslam, Cheryl Battersby, Catherine Beesley, Christina Cole, Helen Campbell, Kim Dalziel, Jon Dorling, Alan Downs, Peter G. Davis, Zoe Daskalopoulou, Amanda Forster, Michaela Graham-Travis, Nigel J. Hall, Marie Hubbard, Madeleine Hurd, Pollyanna Hardy, Rod HuntAnn Kennedy, Andrew King, Louise Linsell, Brett J. Manley, David Murray, Tracy K. Mitchell, Heather O’Connor, Shalini Ojha, Charles C. Roehr, Oliver Rivero-Arias, The neoGASTRIC collaborative group, et al

Bristol Medical School (THS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

Abstract

Background:

Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the aspirate to inform feeding. This is an established practice in many United Kingdom and Australian neonatal units for preterm infants receiving gastric tube feeds. The rationale is to assess feed tolerance and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Routine measurement of gastric residual volumes may also be associated with adverse outcomes and harm, including delayed achievement of full enteral feeds and longer neonatal unit stay. Evidence to support the routine measurement of gastric residuals is poor, and previous small trials have not been generalisable to UK or Australian neonatal care.

Methods:

The aim of the neoGASTRIC trial is to test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for an infant to reach full enteral feeds without increasing necrotising enterocolitis. neoGASTRIC is an individually randomised controlled trial in neonatal units in the UK and Australia. A target of 7040 infants born before 34 weeks’ gestation will be randomly allocated, prior to receiving 24 h of enteral feeds > 15 ml/kg/day, on a 1:1 basis to have no routine gastric residual volumes measured, or to have gastric residual volumes measured routinely. Opt-out consent will be used with parent and staff views explored as part of an embedded process evaluation. The primary superiority outcome is time to reach full milk feeds ≥ 145 ml/kg/day for three consecutive days. Bell’s stage 2 or 3 necrotising enterocolitis following blinded adjudication will be the key secondary, non-inferiority safety outcome. Other neonatal core outcomes and health care resource use and costs prior to discharge will be evaluated.

Discussion:

neoGASTRIC will address a research priority that affects more than 20,000 preterm infants in the United Kingdom and Australia annually. Even modest improvements in clinical outcomes and resource use could result in large clinical benefits and savings at a population level.

Trial registration:

ISRCTN 16710849. Prospectively registered on 8 February 2023.

Original language	English
Number of pages	17
Journal	Trials
Volume	27
Issue number	106
DOIs	https://doi.org/10.1186/s13063-025-09403-7
Publication status	Published - 8 Jan 2026

Bibliographical note

Publisher Copyright:
© The Author(s) 2026.

Keywords

Infant
Neonatal nutrition
Necrotising enterocolitis (NEC)
Gastric tube feeds
Gastric residual volume
Neonatal care
Randomised controlled trial
Protocol
Feeding intolerance
Enteral feeding
Preterm

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Cite this

Nuthall, E., Rodriquez, A., Andrzejewksa, I., Aslam, Z., Battersby, C., Beesley, C., Cole, C., Campbell, H., Dalziel, K., Dorling, J., Downs, A., Davis, P. G., Daskalopoulou, Z., Forster, A., Graham-Travis, M., Hall, N. J., Hubbard, M., Hurd, M., Hardy, P., ... al , E. (2026). Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial. Trials, 27(106). https://doi.org/10.1186/s13063-025-09403-7

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title = "Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial",

abstract = "Background:Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the aspirate to inform feeding. This is an established practice in many United Kingdom and Australian neonatal units for preterm infants receiving gastric tube feeds. The rationale is to assess feed tolerance and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Routine measurement of gastric residual volumes may also be associated with adverse outcomes and harm, including delayed achievement of full enteral feeds and longer neonatal unit stay. Evidence to support the routine measurement of gastric residuals is poor, and previous small trials have not been generalisable to UK or Australian neonatal care. Methods:The aim of the neoGASTRIC trial is to test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for an infant to reach full enteral feeds without increasing necrotising enterocolitis. neoGASTRIC is an individually randomised controlled trial in neonatal units in the UK and Australia. A target of 7040 infants born before 34 weeks{\textquoteright} gestation will be randomly allocated, prior to receiving 24 h of enteral feeds > 15 ml/kg/day, on a 1:1 basis to have no routine gastric residual volumes measured, or to have gastric residual volumes measured routinely. Opt-out consent will be used with parent and staff views explored as part of an embedded process evaluation. The primary superiority outcome is time to reach full milk feeds ≥ 145 ml/kg/day for three consecutive days. Bell{\textquoteright}s stage 2 or 3 necrotising enterocolitis following blinded adjudication will be the key secondary, non-inferiority safety outcome. Other neonatal core outcomes and health care resource use and costs prior to discharge will be evaluated. Discussion:neoGASTRIC will address a research priority that affects more than 20,000 preterm infants in the United Kingdom and Australia annually. Even modest improvements in clinical outcomes and resource use could result in large clinical benefits and savings at a population level. Trial registration:ISRCTN 16710849. Prospectively registered on 8 February 2023.",

keywords = "Infant, Neonatal nutrition, Necrotising enterocolitis (NEC), Gastric tube feeds, Gastric residual volume, Neonatal care, Randomised controlled trial, Protocol, Feeding intolerance, Enteral feeding, Preterm",

author = "Elizabeth Nuthall and Amy Rodriquez and Iza Andrzejewksa and Zainab Aslam and Cheryl Battersby and Catherine Beesley and Christina Cole and Helen Campbell and Kim Dalziel and Jon Dorling and Alan Downs and Davis, \{Peter G.\} and Zoe Daskalopoulou and Amanda Forster and Michaela Graham-Travis and Hall, \{Nigel J.\} and Marie Hubbard and Madeleine Hurd and Pollyanna Hardy and Rod Hunt and Ann Kennedy and Andrew King and Louise Linsell and Manley, \{Brett J.\} and David Murray and Mitchell, \{Tracy K.\} and Heather O{\textquoteright}Connor and Shalini Ojha and Roehr, \{Charles C.\} and Oliver Rivero-Arias and \{The neoGASTRIC collaborative group\} and et al",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2026.",

year = "2026",

month = jan,

day = "8",

doi = "10.1186/s13063-025-09403-7",

language = "English",

volume = "27",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd",

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Nuthall, E, Rodriquez, A, Andrzejewksa, I, Aslam, Z, Battersby, C, Beesley, C, Cole, C, Campbell, H, Dalziel, K, Dorling, J, Downs, A, Davis, PG, Daskalopoulou, Z, Forster, A, Graham-Travis, M, Hall, NJ, Hubbard, M, Hurd, M, Hardy, P, Hunt, R, Kennedy, A, King, A, Linsell, L, Manley, BJ, Murray, D, Mitchell, TK, O’Connor, H, Ojha, S, Roehr, CC, Rivero-Arias, O, The neoGASTRIC collaborative group & al , E 2026, 'Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial', Trials, vol. 27, no. 106. https://doi.org/10.1186/s13063-025-09403-7

Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial. / Nuthall, Elizabeth; Rodriquez, Amy; Andrzejewksa, Iza et al.
In: Trials, Vol. 27, No. 106, 08.01.2026.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial)

T2 - study protocol for a multi-centre, unblinded, randomised, controlled trial

AU - Nuthall, Elizabeth

AU - Rodriquez, Amy

AU - Andrzejewksa, Iza

AU - Aslam, Zainab

AU - Battersby, Cheryl

AU - Beesley, Catherine

AU - Cole, Christina

AU - Campbell, Helen

AU - Dalziel, Kim

AU - Dorling, Jon

AU - Downs, Alan

AU - Davis, Peter G.

AU - Daskalopoulou, Zoe

AU - Forster, Amanda

AU - Graham-Travis, Michaela

AU - Hall, Nigel J.

AU - Hubbard, Marie

AU - Hurd, Madeleine

AU - Hardy, Pollyanna

AU - Hunt, Rod

AU - Kennedy, Ann

AU - King, Andrew

AU - Linsell, Louise

AU - Manley, Brett J.

AU - Murray, David

AU - Mitchell, Tracy K.

AU - O’Connor, Heather

AU - Ojha, Shalini

AU - Roehr, Charles C.

AU - Rivero-Arias, Oliver

AU - The neoGASTRIC collaborative group

AU - al , et

PY - 2026/1/8

Y1 - 2026/1/8

N2 - Background:Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the aspirate to inform feeding. This is an established practice in many United Kingdom and Australian neonatal units for preterm infants receiving gastric tube feeds. The rationale is to assess feed tolerance and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Routine measurement of gastric residual volumes may also be associated with adverse outcomes and harm, including delayed achievement of full enteral feeds and longer neonatal unit stay. Evidence to support the routine measurement of gastric residuals is poor, and previous small trials have not been generalisable to UK or Australian neonatal care. Methods:The aim of the neoGASTRIC trial is to test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for an infant to reach full enteral feeds without increasing necrotising enterocolitis. neoGASTRIC is an individually randomised controlled trial in neonatal units in the UK and Australia. A target of 7040 infants born before 34 weeks’ gestation will be randomly allocated, prior to receiving 24 h of enteral feeds > 15 ml/kg/day, on a 1:1 basis to have no routine gastric residual volumes measured, or to have gastric residual volumes measured routinely. Opt-out consent will be used with parent and staff views explored as part of an embedded process evaluation. The primary superiority outcome is time to reach full milk feeds ≥ 145 ml/kg/day for three consecutive days. Bell’s stage 2 or 3 necrotising enterocolitis following blinded adjudication will be the key secondary, non-inferiority safety outcome. Other neonatal core outcomes and health care resource use and costs prior to discharge will be evaluated. Discussion:neoGASTRIC will address a research priority that affects more than 20,000 preterm infants in the United Kingdom and Australia annually. Even modest improvements in clinical outcomes and resource use could result in large clinical benefits and savings at a population level. Trial registration:ISRCTN 16710849. Prospectively registered on 8 February 2023.

AB - Background:Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the aspirate to inform feeding. This is an established practice in many United Kingdom and Australian neonatal units for preterm infants receiving gastric tube feeds. The rationale is to assess feed tolerance and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Routine measurement of gastric residual volumes may also be associated with adverse outcomes and harm, including delayed achievement of full enteral feeds and longer neonatal unit stay. Evidence to support the routine measurement of gastric residuals is poor, and previous small trials have not been generalisable to UK or Australian neonatal care. Methods:The aim of the neoGASTRIC trial is to test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for an infant to reach full enteral feeds without increasing necrotising enterocolitis. neoGASTRIC is an individually randomised controlled trial in neonatal units in the UK and Australia. A target of 7040 infants born before 34 weeks’ gestation will be randomly allocated, prior to receiving 24 h of enteral feeds > 15 ml/kg/day, on a 1:1 basis to have no routine gastric residual volumes measured, or to have gastric residual volumes measured routinely. Opt-out consent will be used with parent and staff views explored as part of an embedded process evaluation. The primary superiority outcome is time to reach full milk feeds ≥ 145 ml/kg/day for three consecutive days. Bell’s stage 2 or 3 necrotising enterocolitis following blinded adjudication will be the key secondary, non-inferiority safety outcome. Other neonatal core outcomes and health care resource use and costs prior to discharge will be evaluated. Discussion:neoGASTRIC will address a research priority that affects more than 20,000 preterm infants in the United Kingdom and Australia annually. Even modest improvements in clinical outcomes and resource use could result in large clinical benefits and savings at a population level. Trial registration:ISRCTN 16710849. Prospectively registered on 8 February 2023.

KW - Infant

KW - Neonatal nutrition

KW - Necrotising enterocolitis (NEC)

KW - Gastric tube feeds

KW - Gastric residual volume

KW - Neonatal care

KW - Randomised controlled trial

KW - Protocol

KW - Feeding intolerance

KW - Enteral feeding

KW - Preterm

U2 - 10.1186/s13063-025-09403-7

DO - 10.1186/s13063-025-09403-7

M3 - Article (Academic Journal)

C2 - 41501913

SN - 1745-6215

VL - 27

JO - Trials

JF - Trials

IS - 106

ER -