Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563687
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Continuous Glucose Monitoring in HIE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to examine whether the use of continuous glucose monitoring CGM to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed mean glucose values glucose variability within individuals percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges
Randomized controlled trial recruiting neonates Birth weight 18kg Gestation36 weeks with moderate or severe hypoxic ischemic encephalopathy HIE following perinatal asphyxia Neonates will be randomly assigned 11 within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours
Randomized controlled trial recruiting neonates Birth weight 18kg Gestation36 weeks with moderate or severe hypoxic ischemic encephalopathy HIE following perinatal asphyxia Neonates will be randomly assigned 11 within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours
Detailed Description:
Neonatal hypoglycaemia and hyperglycaemia are associated with brain injury and impaired neurodevelopment outcomes in neonates with HIE Improving early glucose control is an important modifiable risk factor for outcomes in this population Glycaemic monitoring is usually performed by capillary or central line sampling However over 30 of the episodes of abnormal glucose concentration are undetected even with regular but intermittent sampling CGM can allow earlier detection and prevention of exposure to extreme glucose concentrations
Study design - This is a multicentre interventional open-label randomized controlled trial of CGM compared with standard clinical management controlA total of 70 neonates Birth weight 18kg Gestation 36 weeks and aged 6hours with moderate or severe HIE following perinatal asphyxia will be recruited within 6 hours of birth after informed parental consent Neonates with major congenital malformations inborn errors of metabolism congenital infections imminent death will be excluded
Neonates will be randomly assigned 11 to receive either the intervention with real-time CGM for 72 hours or standard care using a randomization program R package SRS A Subject Randomization System We will use the minimization method to control for severity and to achieve balance within recruiting centres In all the neonates recruited Dexcom ONE CGM Dexcom San Diego CA USA will be placed soon after study enrollment The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for 72 h The CGM device will be calibrated using blood glucose values measured by point-of-care test CGM calibrations will be performed at least twice a day CGM data will be downloaded by using Dexcom Studio software on a dedicated computer
In the standard care group the CGM device will collect glucose data continuously but the clinical team will be blinded to the data These neonates will have their glucose control monitored and managed according to standard clinical practice using intermittently sampled blood glucose levels In the intervention group the CGM data will be used to support clinical management including blood glucose measurements and decision making Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data
Interventions to target glucose control will be guided by a protocol shared among the participating hospitals As part of the study protocol all the neonates will receive a continuous infusion of glucose 10 of 3-4 mgkgminute and total fluid intake starting at 50-60 mlkgday followed by titration depending on urine output renal function and management of glucose infusion rates
Study design - This is a multicentre interventional open-label randomized controlled trial of CGM compared with standard clinical management controlA total of 70 neonates Birth weight 18kg Gestation 36 weeks and aged 6hours with moderate or severe HIE following perinatal asphyxia will be recruited within 6 hours of birth after informed parental consent Neonates with major congenital malformations inborn errors of metabolism congenital infections imminent death will be excluded
Neonates will be randomly assigned 11 to receive either the intervention with real-time CGM for 72 hours or standard care using a randomization program R package SRS A Subject Randomization System We will use the minimization method to control for severity and to achieve balance within recruiting centres In all the neonates recruited Dexcom ONE CGM Dexcom San Diego CA USA will be placed soon after study enrollment The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for 72 h The CGM device will be calibrated using blood glucose values measured by point-of-care test CGM calibrations will be performed at least twice a day CGM data will be downloaded by using Dexcom Studio software on a dedicated computer
In the standard care group the CGM device will collect glucose data continuously but the clinical team will be blinded to the data These neonates will have their glucose control monitored and managed according to standard clinical practice using intermittently sampled blood glucose levels In the intervention group the CGM data will be used to support clinical management including blood glucose measurements and decision making Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data
Interventions to target glucose control will be guided by a protocol shared among the participating hospitals As part of the study protocol all the neonates will receive a continuous infusion of glucose 10 of 3-4 mgkgminute and total fluid intake starting at 50-60 mlkgday followed by titration depending on urine output renal function and management of glucose infusion rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None