Health Condition 1: null- Levetiracetam in Perinatal Asphyxia
Conditions
Interventions
Intervention1: Levetiracetam: Initial loading dose of 20 mg/kg followed by maintenance dose of 20 mg/kg/day in 2 divided doses to a maximum of 60 mg/kg/day.
Control Intervention1: Phenobarbitone: Init
Sponsors
Sarojini Naidu Children Hospital
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control of Neonatal Seizures with first anticonvulsant Need of second anticonvulsant Neonatal Mortality during first week of life Neurological status at dischargeTimepoint: First week of life (Early Neonatal period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of Levetiracetam Duration of Hospital Stay Neurological Status and Development on follow up visitsTimepoint: First year of life | — |
Countries
India
Contacts
Public ContactDr Manisha Maurya MD
Moti Lal Nehru Medical College Allahabad
Outcome results
None listed