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Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care ‘REACT’
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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 ISSN 2044-6055.
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Official URL: https://doi.org/10.1136/bmjopen-2017-020816
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 | ||||||
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| Subjects: | Q Science > QP Physiology R Medicine > RJ Pediatrics |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| 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 | ||||||
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| Volume: | 8 | ||||||
| Article Number: | e020816 | ||||||
| DOI: | 10.1136/bmjopen-2017-020816 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 27 March 2018 | ||||||
| Date of first compliant Open Access: | 5 November 2018 | ||||||
| RIOXX Funder/Project Grant: |
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