Actively Recruiting
Continuous Glucose Monitoring in HIE
Led by University of Campania Luigi Vanvitelli · Updated on 2024-08-21
70
Participants Needed
3
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Glucose Monitoring in HIE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birth weight >1.8kg
- Gestation >35 weeks
- Aged <6 hours
- Moderate or severe hypoxic ischemic encephalopathy following perinatal asphyxia
You will not qualify if you...
- Major congenital malformations
- Inborn errors of metabolism
- Congenital infections
- Imminent death
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
A.O.S.G. Moscati
Avellino, Italy, 83100
Not Yet Recruiting
2
University of Campania Luigi Vanvitelli
Naples, Italy, 80100
Actively Recruiting
3
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
Naples, Italy, 80131
Not Yet Recruiting
Research Team
P
Paolo Montaldo, PhD
CONTACT
S
Simona Puzone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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