A clinical trial to study the efficacy of the drug, Diazoxide, in n newborn babies with low sugar level
Phase 2
Completed
- Conditions
- Health Condition 1: null- Hyperinsulinemic hypoglycemia, small for date neonates
- Registration Number
- CTRI/2014/05/004617
- Lead Sponsor
- Post graduate institute of medical education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.Inborn babies born >=32 weeks
2.Days of life <=5
3.Small for gestational age, defined as weight less than 10th percentile for that gestation as per Lubchencoâ??s chart
4.Presence of hyperinsulinemic hypoglycemia (RBS value of <50 mg% with any detectable insulin level in serum)
Exclusion Criteria
1. Severe perinatal asphyxia (5 minutes APGAR score <4)
2. Necrotising enterocolitis or any condition where oral feeds are contraindicated at enrolment
3. Major congenital malformations
4.Hypoglycemia attributed to systemic inflammatory response syndrome
5. Congestive cardiac failure
6. Suspecetd endocrine diseases like, congenital adrenal hyperplasia, congenital hypothyroidism
7. Suspected cases of inborn errors of metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The time taken for hypoglycemia controlTimepoint: sugar values in euglycemic range for a period of 72 consecutive hours after starting the therapy
- Secondary Outcome Measures
Name Time Method 1. Total duration of intravenous glucose infusion <br/ ><br>2. Time to attain full feeds @150 ml/kg/day (in days) or 100 % of total daily volume intake as oral feeds <br/ ><br>3. Time to attain euglycemia (in days) (BS 50 mg% for 24 hrs) <br/ ><br>4. Incidence of sepsis (both definite and suspected) <br/ ><br>5. Mortality <br/ ><br>Timepoint: Till discharge from hospital or death