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

Publication Date:
2018-06-05
Publisher:
BMJ Publishing
Electronic ISSN:
2044-6055
Topics:
Medicine
Keywords:
Open access, Paediatrics
Published by:
http://group.bmj.com/
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autor Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
beschreibung 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 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 ISRCTN 12793535; Pre-results.
citation_standardnr 6275991
datenlieferant ipn_articles
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feed_publisher BMJ Publishing
feed_publisher_url http://group.bmj.com/
insertion_date 2018-06-05
journaleissn 2044-6055
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher BMJ Publishing
quelle BMJ Open
relation http://bmjopen.bmj.com/cgi/content/short/8/6/e020816?rss=1
schlagwort Open access, Paediatrics
search_space articles
shingle_author_1 Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
shingle_author_2 Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
shingle_author_3 Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
shingle_author_4 Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
shingle_catch_all_1 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
Open access, Paediatrics
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 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 ISRCTN 12793535; Pre-results.
Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
BMJ Publishing
2044-6055
20446055
shingle_catch_all_2 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
Open access, Paediatrics
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 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 ISRCTN 12793535; Pre-results.
Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
BMJ Publishing
2044-6055
20446055
shingle_catch_all_3 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
Open access, Paediatrics
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 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 ISRCTN 12793535; Pre-results.
Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
BMJ Publishing
2044-6055
20446055
shingle_catch_all_4 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
Open access, Paediatrics
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 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 ISRCTN 12793535; Pre-results.
Beardsall, K., Thomson, L., Guy, C., van Weissenbruch, M. M., Iglesias, I., Muthukumar, P., Somisetty, S. K., Bond, S., Petrou, S., Dunger, D., REACT Investigators, Dunger, Hovorka, Somisetty, Muthukumar, Van weissenbruch, Stuart, Platas
BMJ Publishing
2044-6055
20446055
shingle_title_1 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
shingle_title_2 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
shingle_title_3 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
shingle_title_4 Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
timestamp 2025-06-30T23:35:19.981Z
titel Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
titel_suche Protocol of a randomised controlled trial of real-time continuous glucose monitoring in neonatal intensive care 'REACT
topic WW-YZ
uid ipn_articles_6275991