CTRI/2013/01/003310RecruitingPhase 3
comparison of levetiracetam with phenobarbitone for the treatment of seizure in term and near term neonates.
Not provided1 site in 1 country80 target enrollmentStarted: November 6, 2012Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- control of clinical seizure
Study Overview
Brief Summary
Phenobarbitone is the drug of choice in neonatal seizure but known to have long term effect on neonatal brain..Levetiracetam is a newer antiepileptic and its efficacy not being fully established in neonates. It has not been known to have abnormal nuerological effect instead in previous studies it has been to be proved to have nueroprotective..so it has been compared with phenobarbitone.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 0.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •all newborns <28 days with convulsions of any cause.
Exclusion Criteria
- •babies on mechanical ventilation and with refractory shock.
Outcomes
Primary Outcomes
control of clinical seizure
Time Frame: 24 hrs
Secondary Outcomes
- side effects of levetiracetam(nuerological outcome at age 3,6,12 months)
Investigators
Study Sites (1)
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