CTRI/2016/10/007412RecruitingPhase 4
To Compare Efficacy and Safety of Levetiracetam with Phenobarbitone in Neonates with Perinatal Asphyxia: A Randomized Controlled Trial - LeveNeo Trial
Sarojini Naidu Children Hospital0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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
Investigators
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