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A clinical trial to study the efficacy of the drug, Diazoxide, in n newborn babies with low sugar level

Efficacy of Early Diazoxide Treatment in Hyperinsulinemic Hypoglycemia of Small for gestational Age Neonates: a Randomized, Double-blind, Placebo-controlled Trial- a pilot study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/05/004617
Enrollment
30
Registered
2014-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Hyperinsulinemic hypoglycemia, small for date neonates

Interventions

Intervention1: Intervention - Diazoxide : 3 mg/ kg/ dose three times a day per oral till baby becomes euglycemic for atleast 72 hour duration and attains full enteral feeds (150ml/kg/day) Control Inte

Sponsors

Post graduate institute of medical education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn babies born >=32 weeks 2. Days of life 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

Exclusion criteria

Exclusion criteria: 1. Severe perinatal asphyxia (5 minutes APGAR score 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

Design outcomes

Primary

MeasureTime frame
The time taken for hypoglycemia controlTimepoint: sugar values in euglycemic range for a period of 72 consecutive hours after starting the therapy

Secondary

MeasureTime frame
1. Total duration of intravenous glucose infusion 2. Time to attain full feeds @150 ml/kg/day (in days) or 100 % of total daily volume intake as oral feeds 3. Time to attain euglycemia (in days) (BS 50 mg% for 24 hrs) 4. Incidence of sepsis (both definite and suspected) 5. Mortality Timepoint: Till discharge from hospital or death

Countries

India

Contacts

Public ContactDrBinesh B

PGIMER

kanyapupul@yahoo.com8814208317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026