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dc.contributor.authorBeardsall, Kathryn
dc.contributor.authorThomson, Lynn
dc.contributor.authorGuy, Catherine
dc.contributor.authorvan Weissenbruch, Mirjam M
dc.contributor.authorIglesias, Isabel
dc.contributor.authorMuthukumar, Priya
dc.contributor.authorSomisetty, Sateesh Kumar
dc.contributor.authorBond, Simon
dc.contributor.authorPetrou, Stavros
dc.contributor.authorDunger, David
dc.contributor.authorREACT Investigators
dc.date.accessioned2018-11-19T14:36:57Z
dc.date.available2018-11-19T14:36:57Z
dc.date.issued2018-06-04
dc.identifier.issn2044-6055
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/285415
dc.description.abstractINTRODUCTION: Hyperglycaemia is common in the very preterm infant and has been associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia has proved challenging. The development of real-time continuous glucose monitors (CGM) to inform treatment decisions provides an opportunity to reduce this risk. This study aims to assess the feasibility of CGM combined with a specifically designed paper guideline to target glucose control in the preterm infant. METHODS AND ANALYSES: The Real Time Continuous Glucose Monitoring in Neonatal Intensive Care (REACT) trial is an international multicentre randomised controlled trial. 200 preterm infants ≤1200 g and ≤24 hours of age will be randomly allocated to either real-time CGM or standard care (with blinded CGM data collection). The primary outcome is time in target 2.6-10 mmol/L during the study intervention assessed using CGM. Secondary outcomes include efficacy relating to glucose control, utility including staff acceptability, safety outcomes relating to incidence and prevalence of hypoglycaemia and health economic analyses. ETHICS AND DISSEMINATION: The REACT trial has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge Central); Medical Ethics Review Committee, VU University Medical Centre, Amsterdam, The Netherlands and the Research Ethics Committee, Sant Joan de Déu Research Foundation, Barcelona, Spain. Recruitment began in July 2016 and will continue until mid-2018. The trial has been adopted by the National Institute of Health Research Clinical Research Network portfolio (ID: 18826) and is registered with anInternational Standard Randomised Control Number (ISRCTN registry ID: 12793535). Dissemination plans include presentations at scientific conferences, scientific publications and efforts at stakeholder engagement. TRIAL REGISTRATION NUMBER: ISRCTN12793535; Pre-results.
dc.languageeng
dc.publisherBMJ Journals
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectcontinuous monitoring
dc.subjectglucose
dc.subjecthyperglycaemia
dc.subjecthypoglycaemia
dc.subjectrandomised controlled trial
dc.titleProtocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT'.
dc.typeArticle
prism.endingPagee020816
prism.issueIdentifier6
prism.publicationDate2018
prism.publicationNameBMJ Open
prism.startingPagee020816
prism.volume8
dc.identifier.doi10.17863/CAM.32777
dcterms.dateAccepted2018-03-14
rioxxterms.versionofrecord10.1136/bmjopen-2017-020816
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
rioxxterms.licenseref.startdate2018-06-04
dc.contributor.orcidBeardsall, Kathryn [0000-0003-3582-183X]
dc.contributor.orcidBond, Simon [0000-0003-2528-1040]
dc.contributor.orcidDunger, David [0000-0002-2566-9304]
dc.identifier.eissn2044-6055
dc.publisher.urlhttps://bmjopen.bmj.com/content/8/6/e020816
rioxxterms.typeJournal Article/Review
pubs.funder-project-idNETSCC (None)
cam.issuedOnline2018-06-04
dc.identifier.urlhttps://bmjopen.bmj.com/content/8/6/e020816


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Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International