NCT07401433

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

Efficacy Of Levetiracetam in the Treatment of Neonatal Seizures Presenting at Tertiary Care Hospital.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Hayat Abad Medical Complex, Peshawar · Other Government
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, double-blinded, randomized controlled parallel-group trial conducted in the Neonatal Intensive Care Unit of the Department of Pediatrics, MTI District Head Quarter Hospital, Dera Ismail Khan. The study was carried out over a period of one year after approval from the Institutional Research and Ethics Board. A total of 260 neonates aged 0 to 28 days with clinically diagnosed neonatal seizures were enrolled after obtaining written informed consent from parents or legal guardians. Neonates who were already receiving antiepileptic drugs or had congenital cardiac or renal diseases were excluded. Participants were randomly allocated into two equal groups using a table of random numbers with allocation concealment through sequentially numbered sealed opaque envelopes. Group A received intravenous levetiracetam 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. Group B received phenobarbitone as first-line therapy with a loading dose of 20 mg/kg followed by maintenance dosing. In cases of persistent seizures, phenytoin was added according to standard dosing protocols. No crossover between groups occurred. The primary outcome was seizure cessation within 40 minutes of drug administration. Secondary outcomes included seizure freedom at 24 and 48 hours, recurrence of seizures, mean time to seizure control, adverse effects such as sedation, respiratory suppression, hypotension, and mortality. All patients were monitored in the neonatal intensive care unit for five days and followed for up to 14 weeks after discharge. Data were analyzed using SPSS software. Outcomes were compared between groups to evaluate the efficacy and safety of levetiracetam compared with phenobarbitone-based therapy in the management of neonatal seizures.

Conditions

• Neonatal Seizures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-08
• Primary completion: 2025-03-31
• Completion: 2025-04-10
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Pakistan