A Clinical Study to compare Levetiracetam and Phenobarbitone in Newborns with Birth Asphyxia
Phase 4
- Conditions
- Health Condition 1: null- Levetiracetam in Perinatal Asphyxia
- Registration Number
- CTRI/2016/10/007412
- Lead Sponsor
- Sarojini Naidu Children Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Full term neonates (37 completed weeks to less than 42 weeks of gestational age)
Less than 24 hours of age at presentation
HIE stage II or III (as per Sarnat and Sarnat staging)
Exclusion Criteria
Neonates received at least one dose of anticonvulsants
Severe congenital anomalies or CNS malformations
Convulsions due to hypoglycemia/hypocalcemia
Neonatal Sepsis
Major intracranial hemorrhage
Serum creatinine more than 0.8 mg/dl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method