Comparison of levetiracetam and phenytoin in newborns with refractory seizures
Phase 4
- Conditions
- Health Condition 1: P90- Convulsions of newborn
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Term neonates (up to first 28 days of life) and late preterm neonates (up to 44 weeks postmenstrual age) with persistent seizures despite the administration of phenobarbitone as the first-line anti-seizure medication
Exclusion Criteria
•Seizures secondary to correctable metabolic causes like hypoglycemia, hypocalcemia
•Neonates with major congenital malformations
•Non-availability of parental consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of neonates with seizure control (both clinical and electrographic) for 24 hours after administration of the second-line ASMTimepoint: At 24 hours of drug administration
- Secondary Outcome Measures
Name Time Method •Proportion of neonates with seizure control (both clinical & electrographic) for 1 hour & 48 hours <br/ ><br>•Proportion of neonates with clinical seizure control only & electrographic seizure control only <br/ ><br>•Incidence of adverse events like mortality, hypotension, respiratory depression requiring additional respiratory support, need for mechanical ventilation, bradycardia, etc. <br/ ><br>•Hematological & biochemical abnormalities (anemia, agranulocytosis, pancytopenia, hepatitis etc.) <br/ ><br>•Duration of hospital stay <br/ ><br>Timepoint: At the time of hospital discharge