The Neurocognitive Developmental Outcomes Study is a retrospective, observational cohort study designed to compare the long-term neurocognitive outcomes of neonates treated with lacosamide versus other antiseizure medications (ASMs) for neonatal seizures. Neonatal seizures, which occur in 1.4 to 3.6 per 1,000 live births, are associated with poor neurodevelopmental outcomes, including cognitive delays and increased risk of cerebral palsy.
This study will leverage data from the PEDSnet clinical research network, which includes over 13 million pediatric patient records from leading hospitals across the U.S. The study will examine neurocognitive outcomes in neonates treated with lacosamide or other ASMs at 1 and 2 years post-treatment, using neurocognitive assessments such as Bayley’s and SNOMED codes to track development.
The study will also explore adverse events, mortality rates, and healthcare resource utilization across both treatment groups. By matching neonates by age, sex, and other factors, this study aims to provide valuable real-world evidence on the safety and efficacy of lacosamide compared to other ASMs. Findings from this study will help guide treatment strategies for neonates with seizures.