Clinical Trial

Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.

Study acronym: LEV-NEO
Completed
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Summary
Neonatal seizures are a common neurological emergency in newborn babies and can lead to serious brain injury if not treated promptly. Phenobarbitone is commonly used as first-line treatment, but it is associated with delayed seizure control and adverse effects such as sedation and poor feeding. This study was conducted to compare the effectiveness and safety of levetiracetam with conventional antiepileptic drugs (phenobarbitone with or without phenytoin) in the treatment of neonatal seizures. In this randomized controlled trial, newborns aged 0 to 28 days diagnosed with seizures were randomly assigned to receive either intravenous levetiracetam or phenobarbitone-based therapy. The main outcomes assessed were seizure control within 40 minutes, seizure freedom at 24 and 48 hours, recurrence of seizures, time taken to control seizures, adverse effects, and mortality. The results of this study aim to provide evidence on whether levetiracetam is a safer and more effective alternative for managing neonatal seizures in a tertiary care hospital setting.
Trial Details
NCT Number NCT07401433
Lead Sponsor Hayat Abad Medical Complex, Peshawar
Collaborators: Gomal Medical College
Conditions Neonatal Seizures
Enrollment 260 participants
Start Date 2024-04-08
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-10