Clinical Research Directory
Browse clinical research sites, groups, and studies.
Continuous Glucose Monitoring in HIE
Sponsor: University of Campania Luigi Vanvitelli
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.
Official title: Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
Any - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-08-01
Completion Date
2026-12-01
Last Updated
2024-08-21
Healthy Volunteers
No
Interventions
Dexcom ONE+
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)
A.O.S.G. Moscati
Avellino, Italy
University of Campania Luigi Vanvitelli
Naples, Italy
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
Naples, Italy