Oral glucose solution for the treatment of neonatal hypoglycemia
Phase 2
- Conditions
- neonatal hypoglycemiaoral glucose solutionpostnatal hypoglycemia in late preterm and term infantsasymptomatic hypoglycemia
- Registration Number
- TCTR20181204005
- Lead Sponsor
- the Siriraj Research Development Fund (Managed by Routine to Research: R2R).
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
1. At least 34-week's GA
2. At least 1 risk factor of postnatal hypoglycemia (preterm, maternal diabetes, SGA, LGA, birthweight less than 2500g or more than 4000g)
3. Asymtomatic hypoglycemia
4. Age less than 48 hours
5. No contraindication of oral feedings
6. Parental written consent
Exclusion Criteria
1. Blood glucose less than 25 mg/dL
2. IV fluid is indicated from other reasons
3. Major anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proportion of infants require IV glucose administration within 48 hours present of having IV fluid for glucose admistration
- Secondary Outcome Measures
Name Time Method incidence of hyperglycemia during 48 hours number of infants in each arm who have blood glucose >180 mg/dL,days of full enteral feedings during birth hospitalization postnatal days at reaching enteral feeding