Health Condition 1: null- newborns with seizures
Conditions
Interventions
Intervention1: Effect of post seizure prophylaxis of phenobarbitone in neonatal seizures: a randomized control trial: control group:phenobarbitone
comparator agent:Normal saline
Intervention2: give ph
Sponsors
NIL
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2.Till Six months of age: neurological and developmental evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare two groups with respect to: 1.Time to full oral feeding. 2.Duration of stay in hospital 3.EEG & MRI changes before discharge. 4.Neurodevelopmental status at discharge,3 & 6 months. 5.Seizure recurrence rate up to 6 months of age.Timepoint: same as above as mention in primary outcome time points | — |
Countries
India
Contacts
Public ContactAMIT UPADHYAY
L.L.R.M COLLEGE,MEERUT
Outcome results
None listed