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Continuous Glucose Monitoring in HIE

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 21, 2024 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06563687
Lead Sponsor University of Campania Luigi Vanvitelli
Conditions
(from sponsor)		 Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia, Hypoglycemia
Related terms Hyperglycemia, Hypoglycemia
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov