A clinical trial to compare the efficacy of phenobarbitone with levetiracetam for the treatment of seizures (fits) in newborns
Not Applicable
Completed
- Conditions
- Health Condition 1: null- neonatal seizures
- Registration Number
- CTRI/2011/07/001863
- Lead Sponsor
- DR AMIT UPADHYAY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.patients with clinically apparent seizures with perinatal asphyxia, and HIE With weight greater than 2 kg.
2. patient with seizures not responding to treatment of hypoglycemia, hypocalcemia.
Exclusion Criteria
1.Serum creatinine greater than 1.2 at enrollment or greater than 2 at any time.
2.Major congenital malformations
3.Sick neonates with significant respiratory distress requiring assisted ventilation,ionotropic support,symptomatic hypocalcemia/hypoglycemia,renal/cardiac failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical control of seizuresTimepoint: 12 hrs from last episode of seizures
- Secondary Outcome Measures
Name Time Method Incidence of electrical seizures after control of clinical seizuresTimepoint: At 3 months and at 6 months of age.;Neurological examinationTimepoint: At time of discharge, at 3 months and at 6 months.;Safety profile of levetiracetam.Timepoint: At 3 and 6 months of age;Time taken to control clinical seizuresTimepoint: At the time of admission