Beardsall, Kathryn, Thomson, Lynn, Guy, Catherine, van Weissenbruch, Mirjam M., Iglesias, Isabel, Muthukumar, Priya, Somisetty, Sateesh Kumar, Bond, Simon, Petrou, Stavros and Dunger, David (2018) Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care ‘REACT’. BMJ Open, 8 . e020816. doi:10.1136/bmjopen-2017-020816

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Abstract

Introduction

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 REACT Randomised controlled Trial (Real Time Continuous Glucose Monitoring in Neonatal Intensive Care) is an international multicentre randomised controlled trial. Two hundred preterm infants ≤1200g, and ≤24 hours of age will be randomly allocated to either real time continuous glucose monitoring, or standard care (with blinded CGM data collection). The primary outcome is time in target 2.6-10mmol/l during the study intervention assessed using continuous glucose monitoring. 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 NHS 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 the ISRCTN registry (ID: 12793535). Dissemination plans include presentations at scientific conferences, scientific publications and efforts at stakeholder engagement.

Item Type:	Journal Article
Subjects:	Q Science > QP Physiology R Medicine > RJ Pediatrics
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Hyperglycaemia, Premature infants, Neonatal intensive care
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	4 June 2018
Dates:	Date Event 4 June 2018 Published 14 March 2018 Accepted
Date of first compliant deposit:	27 March 2018
Volume:	8
Article Number:	e020816
DOI:	10.1136/bmjopen-2017-020816
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID UNSPECIFIED [NIHR] National Institute for Health Research http://dx.doi.org/10.13039/501100000272
Related URLs:	Publisher
Contributors:	Contribution Name Contributor ID Research Group REACT Investigators, UNSPECIFIED

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