Continuous Glucose Monitoring in HIE
Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
University of Campania Luigi Vanvitelli
70 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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 \>1.8kg, Gestation\>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.
Eligibility
Inclusion Criteria4
- Birth weight \>1.8kg
- Gestation \>35 weeks
- Aged \<6hours
- Moderate or severe HIE following perinatal asphyxia
Exclusion Criteria4
- Major congenital malformations
- Inborn errors of metabolism,
- Congenital infections
- Imminent death
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Interventions
In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06563687