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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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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\u00a0weeks\u2019 gestation will be randomly allocated, prior to receiving 24\u00a0h of enteral feeds\u2009>\u200915\u00a0ml\/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\u2009\u2265\u2009145\u00a0ml\/kg\/day for three consecutive days. Bell\u2019s 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.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n ISRCTN 16710849<\/jats:ext-link>\n . Prospectively registered on 8 February 2023.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-025-09403-7","type":"journal-article","created":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T02:56:04Z","timestamp":1767840964000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Avoiding routine gastric residual volume measurement in neonatal critical care (the neoGASTRIC trial): study protocol for a multi-centre, unblinded, randomised, controlled 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Pediatr Clin North Am. 1986;33(1):179\u2013201.","journal-title":"Pediatr Clin North Am"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-025-09403-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-025-09403-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-025-09403-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T08:48:58Z","timestamp":1770281338000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-025-09403-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,8]]},"references-count":37,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["9403"],"URL":"https:\/\/doi.org\/10.1186\/s13063-025-09403-7","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,8]]},"assertion":[{"value":"18 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 December 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 January 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The neoGASTRIC trial was approved by the London \u2013 Riverside Research Ethics Committee on 8 February 2023, Ref: 23\/LO\/0060, and the Monash Health Human Research Ethics Committee on 30 March 2023, Ref: RES-22-0000-724A. The neoGASTRIC trial will use an opt-out approach to consent. Parents or carers will be informed about neoGASTRIC through posters, a leaflet and\/or electronic media given when their infant is admitted to the neonatal unit. Study information will be made available to parents\/carers prior to randomisation. After this information is made available, infants meeting the eligibility criteria will automatically be included in the trial unless parents express a wish for them not to (to opt out of trial participation).Opt-out consent will cover data linkage to routinely recorded long-term outcome data (for UK trial participants this will be NNRD, Hospital Episode Statistics and the National Pupil Database) and for Australian trial participants this will be administrative hospital costing records from individual participating hospitals.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {30}"}},{"value":"CG is chair of the NIHR Research for Patient Benefit Regional Assessment Panel, London; CG has received grant funding for research from the NIHR (including for neoGASTRIC), the MRC, Action Medical Research, Rosetrees Foundation and Chiesi Pharmaceuticals. CR has received grant funding for research from the NHMRC (including for neoGASTRIC), Heart Foundation of Australia, Cerebral Palsy Alliance (Australia), Royal Australasian College of Physicians, and Chiesi Pharmaceuticals. CB is supported by a Personal fellowship awarded by the UK National Institute for Health and Care Research (NIHR) All other authors have nothing to declare.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {7b}"}}],"article-number":"106"}}