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

NCT07401433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Neonatal Seizures

Interventions

DRUG

Levetiracetam

Neonates with clinically diagnosed seizures received intravenous levetiracetam as the first-line anticonvulsant. Levetiracetam was administered at a rate of 1 mg/kg/min followed by a loading dose of 20 mg/kg diluted in normal saline. Maintenance therapy of 20 mg/kg/day was continued after seizure control. Seizure response and adverse effects were monitored.

DRUG

Phenobarbital Sodium Injection

Phenobarbitone will be administered intravenously as the first-line anticonvulsant for neonatal seizures. Initial loading dose 20 mg/kg IV. If seizures persist after 20 minutes, a second dose of 10 mg/kg IV will be given. Maintenance dose of 5 mg/kg IV/PO once daily will be continued until seizure control is achieved or until discharge. Seizure response and adverse effects will be monitored.

Sponsors & Collaborators

  • Gomal Medical College

    collaborator OTHER

  • Hayat Abad Medical Complex, Peshawar

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2025-03-31
Completion
2025-04-10

Countries

  • Pakistan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401433 on ClinicalTrials.gov