Levetiracetam versus Phenobarbitone in Neonatal Seizures - An Open label Randomized Controlled Trial

Authors

  • Nikhil D. Kulkarni Department of Neonatology, St. John’s Medical College Hospital, Bangalore, Karnataka
  • Suman Rao P. N. Prof & Head, Department of Neonatology, St. John’s Medical College Hospital, Bangalore, Karnataka
  • B. Lakshmi Parvathi Department of Neonatology, St. John’s Medical College Hospital, Bangalore, Karnataka
  • Swarnarekha Bhat Department of Neonatology, St. John’s Medical College Hospital, Bangalore, Karnataka

DOI:

https://doi.org/10.26463/rjns.15_1_10

Keywords:

Neonatal seizures, Phenobarbitone, Levetiracetam, Efficacy, Neonatal intensive care unit

Abstract

Background: Phenobarbitone is the traditional first-line anticonvulsant for neonatal seizures, while levetiracetam, a newer anti-epileptic, has uncertain efficacy in comparison

Objective: To evaluate the efficacy and safety of levetiracetam versus phenobarbitone in term and preterm infants with clinically apparent seizures in a tertiary care neonatal setting, guiding safer, more effective neonatal seizure management

Methods: This study aimed to compare the efficacy and safety of levetiracetam (30 mg/kg/dose) and phenobarbitone (20 mg/kg/dose) in controlling neonatal seizures. An open-label, parallel randomized controlled trial (RCT) was conducted in a neonatal intensive care unit (NICU) in India

Results: Seizure cessation rates were 70% in the levetiracetam group and 66.6% in the phenobarbitone group, with no statistically significant difference (P = 0.83).

Conclusion: Levetiracetam and phenobarbitone demonstrated comparable efficacy and safety in managing neonatal seizures. Levetiracetam could be considered a viable alternative to phenobarbitone as a first-line treatment. Further studies are needed to confirm these findings, especially regarding levetiracetam's side effect profile.

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Published

2025-12-29

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Original Articles