Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care ‘REACT’

Abstract

IntroductionHyperglycaemia 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 analysesThe 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 disseminationThe 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 numberISRCTNNCT12793535Pre-results.

Nurses’ Performance in Caring of Neonates undergoing Exchange Blood Transfusion in Neonatal Intensive Care Units

“…Observational checklists was adopted from Beardsall, et al, (2018), Perry & Lebon, (2015), Lynn &Lebon (2014) andMacDonald, et al, (2012). It was used to assess nurses practice regarding care of neonates undergo exchange transfusion.…”

Strict glycaemic control in very low birthweight infants using a continuous glucose monitoring system: a randomised controlled trial

“…The CGM also detected clinically unsuspected episodes of hypoglycaemia. 28 Galderisi et al demonstrated that compared with standard treatment, CGM-guided glucose titration and glucose administration using a proportional-integrative-derivative control algorithm can increase the time spent in an optimal glycaemia range defined as 4-7.99 mmol/L (72-144 mg/dL) and minimise glycaemic variability in infants born ≤32 weeks' gestation or birth weight ≤1500 g during the first week of life. 13 The use of insulin infusion and its safety to control hyperglycaemia has been previously evaluated.…”

The Impact of 2 Weight-Based Standard Parenteral Nutrition Formulations Compared With One Standard Formulation on the Incidence of Hyperglycemia and Hypernatremia in Low Birth-Weight Preterm Infants

“…An initial comparison with standard-of-care intermittent blood glucose sampling demonstrated a greater percentage of time spent in euglycemic range, less time in mild or severe hypoglycemia, less time in severe hyperglycemia, and reduced glucose variability. 29 If validation of the short-term safety and efficacy and positive long-term outcomes becomes available in future randomized controlled trials, 30 this type of technology could play a role in the future nutritional management of low birth-weight infants.…”