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Does Levetiracetam reduce death/ control fits better than phenobarbitone in neonates

Levetiracetam vs Phenobarbitone for the control of neonatal seizures: A double blind randomised controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/06/004659
Enrollment
300
Registered
2014-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Neonatal seizures

Interventions

Intervention1: levetiracetam: babies will receive initial loading of i.v levetiracetam 20mg/kg over 20 minutes followed by loading doses of 20mg/kg upto maximum 60mg/kg if seizures are persistent. Mai

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Babies admitted to NICU with clinical seizures and babies who develop clinical seizures during NICU stay with ï?§ Gestational age >= 32 wks ï?§ Birth weight >= 1500g ï?§ Chronological age

Exclusion criteria

Exclusion criteria: Babies admitted to NICU with seizures and babies who develop seizures during NICU stay with ï?§ Seizures due to hypoglycemia and hypocalcemia ï?§ Serum creatinine >2mg/dl ï?§ Major congenital anomalies ï?§ Prior use of any other anticonvulsants

Design outcomes

Primary

MeasureTime frame
Mortality and times taken for the clinical control of seizures upto 30 days of age or at discharge whichever is earlierTimepoint: Mortality and times taken for the clinical control of seizures upto 30 days of age or at discharge whichever is earlier

Secondary

MeasureTime frame
Adverse events and side effects between the two groups during hospital stayTimepoint: Adverse events and side effects between the two groups during hospital stay;All cause death/ neurodevelopmental delay at 18 months of age Timepoint: All cause death/ neurodevelopmental delay at 18 months of age

Countries

India

Contacts

Public Contactshruthi k bharadwaj

JIPMER

drvishnubhat@yahoo.com9842351282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026