Status:
RECRUITING
Continuous Glucose Monitoring in HIE
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Hypoxic Ischemic Encephalopathy of Newborn
Hyperglycemia
Eligibility:
All Genders
Up to 6 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- Birth weight \>1.8kg
- Gestation \>35 weeks
- Aged \<6hours
- Moderate or severe HIE following perinatal asphyxia
Exclusion
- Major congenital malformations
- Inborn errors of metabolism,
- Congenital infections
- Imminent death
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06563687
Start Date
August 1 2024
End Date
December 1 2026
Last Update
August 21 2024
Active Locations (3)
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1
A.O.S.G. Moscati
Avellino, Italy, 83100
2
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
Naples, Italy, 80131
3
University of Campania Luigi Vanvitelli
Napoli, Italy, 80100