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

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.

Timeline

Start

2024-04-08

Primary completion

2025-03-31

Completion

2025-04-10

Publications

• Results Isguder R, Guzel O, Agin H, Yilmaz U, Akarcan SE, Celik T, Unalp A. Efficacy and safety of IV levetiracetam in children with acute repetitive seizures. Pediatr Neurol. 2014 Nov;51(5):688-95. doi: 10.1016/j.pediatrneurol.2014.07.021. Epub 2014 Jul 22.
• Results Khan O, Cipriani C, Wright C, Crisp E, Kirmani B. Role of intravenous levetiracetam for acute seizure management in preterm neonates. Pediatr Neurol. 2013 Nov;49(5):340-3. doi: 10.1016/j.pediatrneurol.2013.05.008. Epub 2013 Aug 3.
• Results Sourbron J, Chan H, Wammes-van der Heijden EA, Klarenbeek P, Wijnen BFM, de Haan GJ, van der Kuy H, Evers S, Majoie M. Review on the relevance of therapeutic drug monitoring of levetiracetam. Seizure. 2018 Nov;62:131-135. doi: 10.1016/j.seizure.2018.09.004. Epub 2018 Sep 12.
• Results Efficacy of levetiracetam as the first line antiepileptic drug in neonatal seizures (ResearchGate PDF).
• Results Sharpe C, Reiner GE, Davis SL, Nespeca M, Gold JJ, Rasmussen M, Kuperman R, Harbert MJ, Michelson D, Joe P, Wang S, Rismanchi N, Le NM, Mower A, Kim J, Battin MR, Lane B, Honold J, Knodel E, Arnell K, Bridge R, Lee L, Ernstrom K, Raman R, Haas RH; NEOLEV2 INVESTIGATORS. Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial. Pediatrics. 2020 Jun;145(6):e20193182. doi: 10.1542/peds.2019-3182. Epub 2020 May 8.
• Results McHugh DC, Lancaster S, Manganas LN. A Systematic Review of the Efficacy of Levetiracetam in Neonatal Seizures. Neuropediatrics. 2018 Feb;49(1):12-17. doi: 10.1055/s-0037-1608653. Epub 2017 Nov 27.
• Results Weldegerima K, Gebremariam DS, Haftu H, Berhe G, Hadgu A, Mohammedamin MM. Neonatal Seizure Pattern, Outcome, and its Predictors Among Neonates Admitted to NICU of Ayder Comprehensive Specialized Hospital, Mekelle, Tigray, Ethiopia. Int J Gen Med. 2023 Sep 25;16:4343-4355. doi: 10.2147/IJGM.S414420. eCollection 2023.
• Results Kaminiow K, Kozak S, Paprocka J. Neonatal Seizures Revisited. Children (Basel). 2021 Feb 18;8(2):155. doi: 10.3390/children8020155.
• Results Ramantani G, Schmitt B, Plecko B, Pressler RM, Wohlrab G, Klebermass-Schrehof K, Hagmann C, Pisani F, Boylan GB. Neonatal Seizures-Are We there Yet? Neuropediatrics. 2019 Oct;50(5):280-293. doi: 10.1055/s-0039-1693149. Epub 2019 Jul 24.

Drugs

Indications