Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures
Phase 3
- Conditions
- eonatal Seizure.Convulsions of newborn
- Registration Number
- IRCT20230415057911N2
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
Neonates with seizure who did not respond to phenobarbital (dose40 mg/kg) and Levebel (40 mg/kg).
Infants under 3 months with refractory seizures whose seizures have started since infancy (under one month).
Seizures due to secondary abnormalities in asphyxia, brain structural disorders, familial seizures, congenital and acquired infections, vascular lesions
Exclusion Criteria
Seizures that started after neonatal Period
Seizures due to secondary abnormalities in metabolic disorders or electrolyte disorders.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of seizures. Timepoint: Before the intervention, 3 days and 7 days after the intervention. Method of measurement: Electroencephalography (EEG).
- Secondary Outcome Measures
Name Time Method