| Title: |
Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled trial |
| Authors: |
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; Kayleigh Stanbury; Jacqueline Taylor; Lyvonne Tume; Richard Welsh; Joy Wiles; Kerry Woolfall; Lauren Young; Calum Roberts; Chris Gale; the neoGASTRIC collaborative group |
| Source: |
Trials, Vol 27, Iss 1, Pp 1-17 (2026) |
| Publisher Information: |
BMC |
| Publication Year: |
2026 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
Infant; Preterm; Enteral feeding; Gastric residual volume; Necrotising enterocolitis (NEC); Neonatal care; Medicine (General); R5-920 |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://doi.org/10.1186/s13063-025-09403-7; https://doaj.org/toc/1745-6215; https://doaj.org/article/e79d6731380744ce8871852a973ea93f |
| DOI: |
10.1186/s13063-025-09403-7 |
| Availability: |
https://doi.org/10.1186/s13063-025-09403-7; https://doaj.org/article/e79d6731380744ce8871852a973ea93f |
| Accession Number: |
edsbas.F8060C81 |
| Database: |
BASE |