Do newborns with single episode of convulsions need continued treatment with phenobarbitone
Phase 3
- Conditions
- Health Condition 1: null- newborns with seizures
- Registration Number
- CTRI/2012/11/003122
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.equal or more than 35 week gestation
2.equal or more than 2 kg
3.equal or less than 15days postnatal age
Exclusion Criteria
1.Recurrence of seizure episode within 12 hrs of first loading dose of phenobarbital.
2.Major congenital malformations.
3.Hepatospleenomegaly(raising doubts of storage disease or intrauterine infections).
4.Suspected chromosomal abnormalities(based on facial dysmorphism and other phenotypic abnormalities)which itself are linked with cognitive and mental problems.
5.Very sick infans requiring assisted ventilation at admission.However,babies who get intubated after randomization will not be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare proportion of babies developing breakthrough seizures in next 5 days in groups receiving maintenance therapy of phenobarbitone(5 mg/kg/days) in two divided doses)versus who do not receive maintenance dose of phenobarbitone 12 hrs after giving its loading dose.Timepoint: 1.Breakthrough seizure within next 5 days of randomization <br/ ><br>2.Till Six months of age: neurological and developmental evaluation.
- Secondary Outcome Measures
Name Time Method To compare two groups with respect to: <br/ ><br>1.Time to full oral feeding. <br/ ><br>2.Duration of stay in hospital <br/ ><br>3.EEG & MRI changes before discharge. <br/ ><br>4.Neurodevelopmental status at discharge,3 & 6 months. <br/ ><br>5.Seizure recurrence rate up to 6 months of age.Timepoint: same as above as mention in primary outcome time points