Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• Birth weight \>1.8kg

• Gestation \>35 weeks

• Aged \<6hours

• Moderate or severe HIE following perinatal asphyxia

Locations
Other Locations
Italy
A.O.S.G. Moscati
NOT_YET_RECRUITING
Avellino
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
NOT_YET_RECRUITING
Naples
University of Campania Luigi Vanvitelli
RECRUITING
Napoli
Contact Information
Primary
Paolo Montaldo, PhD
paolo.montaldo@unicampania.it
0815664023
Backup
Simona Puzone, MD
simona.puzone@unicampania.it
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 70
Treatments
Experimental: Experimental: Unblinded CGM
CGM data will be unblinded, with alarms on for hypo and hyperglycemia. 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 or before any treatment.
Other: Blinded CGM
CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations.
Sponsors
Leads: University of Campania Luigi Vanvitelli

This content was sourced from clinicaltrials.gov