To see if Levetiracetam, a new seizure control medication is better over older medication Phenobarbitone for immediate neonatal seizure control.
Phase 3
Completed
- Conditions
- Health Condition 1: null- neonatal seizures
- Registration Number
- CTRI/2015/06/005849
- Lead Sponsor
- Dr Nikhil D Kulkarni
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
1) > 1000 g birth weight and > 28 weeks gestation.
2)all term neonates
Exclusion Criteria
1)hypoglycemic seizures
2)neonates treated with anticonvulsants prior to admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of seizure and need for another anticonvulsant.Timepoint: Immediately on the day of seizure i.e. within 24 hours.
- Secondary Outcome Measures
Name Time Method Monitoring of adverse drug reactions of each drug like Phenobarbitone toxicity, mortality and neurodevelopmental follow up in follow up clinic.Timepoint: After treatment of seizures within 7 days and on followup at 1 month, 3 months,6 months, 9 months, 12 months, 15 months, 18 months and 24 months.