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Completed

NCT Number: NCT07401433

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

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.

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Key information

Conditions

Neonatal Seizures

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gomal Medical College

Dera Ismāīl Khān, KPK, 29111, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates (0-28 days old) with clinically diagnosed seizures.
  • Both term and preterm neonates.
  • Admitted to the neonatal intensive care unit (NICU) or pediatric ward.
  • Written informed consent obtained from parents or legal guardians.

Exclusion criteria

  • Neonates with major congenital anomalies or genetic syndromes.
  • Neonates with severe renal or hepatic impairment.
  • Neonates with metabolic disorders requiring specific treatment (e.g., hypoglycemia, hypocalcemia) unless seizures persist after correction.
  • Neonates already receiving anticonvulsant therapy prior to admission.
  • Neonates with confirmed meningitis or central nervous system infections requiring specific management (unless seizures persist after appropriate treatment).
  • Neonates with life-threatening conditions where study treatment cannot be safely administered.
  • Parents or legal guardians refusing consent.

Treatment and study plan

Levetiracetam

Drug

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.

Phenobarbital Sodium Injection

Drug

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.

Primary outcomes

  1. Seizure Cessation Within 40 Minutes

    Time frame: Immediately after first-line drug administration (within 40 minutes)

    Proportion of neonates with clinically diagnosed seizures whose seizures stopped completely within 40 minutes after administration of the first-line anticonvulsant.

Secondary outcomes

  1. Time to Seizure Cessation

    Time frame: From first-line drug administration to seizure cessation (up to 40 minutes)

    Time duration from administration of the first dose to complete cessation of seizures.

  2. Need for Second-Line Anticonvulsant

    Time frame: Immediately after first-line treatment failure (within 40 minutes of initial drug administration)

    Proportion of neonates requiring second-line anticonvulsant therapy due to failure of initial treatment.

  3. Seizure Recurrence During Hospital Stay

    Time frame: From initial seizure control through 7 days of hospitalization

    Number of neonates who develop recurrent seizures after initial control during the hospital stay.

  4. Incidence of Adverse Drug Reactions

    Time frame: From first drug administration through the first 5 days of hospitalization

    Incidence of adverse effects (e.g., sedation, hypotension, respiratory depression, rash, feeding intolerance) associated with levetiracetam or phenobarbitone.

  5. Mortality

    Time frame: From enrollment through assessment at discharge, 28 days and 90days

    Number of deaths occurring during hospital stay among neonates treated with levetiracetam or phenobarbitone.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Collaborators

  • Gomal Medical College

Registry information

Official study title

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

Acronym: LEV-NEO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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