Health Condition 1: P90- Convulsions of newborn
Conditions
Interventions
Intervention1: Inj. Levetiracetam: Inj. Levetiracetam,
I/V,
1st Loading - 20 mg/kg - stat,
2nd Loading - 10 mg/kg - SOS (if seizure is not controlled by first loading),
Maintenance - 10 mg/kg - BD,
S
Sponsors
Dr Devdarshan Nitin Gandhi
Eligibility
Inclusion criteria
Inclusion criteria: All inborn and outborn neonates (age 0-28 days) between 35 weeks to 42 weeks of gestational age admitted in NICU with clinical seizures will be enrolled in the study. For this study we will be considering subtle seizure, tonic seizures, clonic seizures and myoclonic seizures.
Exclusion criteria
Exclusion criteria: --Major congenital malformation --Need for assisted ventilation at the time of admission --Refractory shock --Serum creatinine >2 mg/dl --Anticonvulsant prior to admission --Neonates with hypoglycaemia, hypocalcemia or hypo / hyperkalemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Levetiracetam versus Phenobarbitone in controlling neonatal seizures.Timepoint: Whether seizure is controlled within 1 hour or not. And time taken for clinical control of seizure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effect: Heart rate fluctuationsTimepoint: Within 8 hours of administration of drug;Adverse effect: Respiratory depression / Apnoea / DesaturationTimepoint: Within 8 hours of administration of drug;Duration of hospitalizationTimepoint: Number of days child was admitted in NICU;Recurrence of seizureTimepoint: Within 24 hours of administration of the 1st or 2nd loading dose. | — |
Countries
India
Contacts
Public ContactDr Devdarshan Nitin Gandhi
Narayan Medical College and Hospital
Outcome results
None listed