Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial
Not Applicable
- Conditions
- Prematurity
- Registration Number
- JPRN-UMIN000032812
- Lead Sponsor
- Catholic University of Sacred Heart, Department of Pediatrics, Division of Neonatology
- Brief Summary
Dysglycaemic episodes and of infants with at least one episode of dysglycaemia was significantly lower in the intervention group: respectively 1 IQR 0 2 vs 3 IQR 1 7 p=0.005 and 12 52% vs 20 83% p=0.047. Infants managed using the strict protocol had a higher probability to have normal glycaemic values: relative risk 2.87 95% CI 1.1 to 7.3. The number needed to treat to avoid dysglycaemia episodes is 3.2 95% CI 1.8 to 16.6
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
1. Preterm infants with major congenital anomalies or chromosomic anomalies. 2. Infants not achieving a continuous glucose monitoring for more than 96 hours 3. Infants that need more than one replacement of the subcutaneous sensor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method