Health Condition 1: P90- Convulsions of newborn
Conditions
Interventions
Intervention1: Levetiracetam injection: Levetiracetam will be administered at a loading dose of 40 mg per kg infusion over 20 minutes, with an additional loading of 20 mg per kg if seizures persist.
C
Sponsors
All India Institute of Medical Sciences, Rishikesh
Mayank Priyadarshi
Eligibility
Inclusion criteria
Inclusion criteria: Term neonates (up to first 28 days of life) and late preterm neonates (up to 44 weeks postmenstrual age) with persistent seizures despite the administration of phenobarbitone as the first-line anti-seizure medication
Exclusion criteria
Exclusion criteria: � Seizures secondary to correctable metabolic causes like hypoglycemia, hypocalcemia � Neonates with major congenital malformations � Non-availability of parental consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of neonates with seizure control (both clinical and electrographic) for 24 hours after administration of the second-line ASMTimepoint: At 24 hours of drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Proportion of neonates with seizure control (both clinical & electrographic) for 1 hour & 48 hours ââ?¬Â¢ Proportion of neonates with clinical seizure control only & electrographic seizure control only ââ?¬Â¢ Incidence of adverse events like mortality, hypotension, respiratory depression requiring additional respiratory support, need for mechanical ventilation, bradycardia, etc. ââ?¬Â¢ Hematological & biochemical abnormalities (anemia, agranulocytosis, pancytopenia, hepatitis etc.) ââ?¬Â¢ Duration of hospital stay Timepoint: At the time of hospital discharge | — |
Countries
India
Contacts
Public ContactMayank Priyadarshi
AIIMS Rishikesh
Outcome results
None listed