Long-term Neurocognitive Effects in Neonates Following Treatment with Lacosamide


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dc.contributorUCB Pharma (United States)
dc.contributor.authorKaur, Maninder
dc.contributor.authorForrest, Christopher
dc.contributor.otherChildren's Hospital of Philadelphia
dc.date.accessioned2024-10-25T21:12:02Z
dc.descriptionThe 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 leverages 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​.
dc.description.abstractStudy to compare the long-term neurocognitive outcomes of neonates treated with lacosamide versus other antiseizure medications (ASMs) for neonatal seizures.
dc.identifier.urihttps://hdl.handle.net/20.500.14642/863
dc.publisherPEDSnet
dc.relation.isreferencedbyKaur M, Utidjian L, Abend NS, Dickinson K, et al. June 2024. "Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal Seizures." _Pediatr Neurol_. 155:18-25. DOI: [10.1016/j.pediatrneurol.2024.03.007](doi.org/10.1016/j.pediatrneurol.2024.03.007)
dc.rightsa CC-BY 4.0 Attribution license.
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.subjectPEDSnet Data Source
dc.subjectIndustry-Funded Research
dc.subjectRetrospective Study
dc.subjectCohort Study
dc.subject.meshEpilepsy
dc.subject.meshOutcome Assessment, Health Care
dc.subject.meshAnticonvulsants
dc.subject.meshCentral Nervous System Agents
dc.subject.meshPharmacological Agents
dc.subject.meshLacosimide
dc.subject.meshNervous System Diseases
dc.titleLong-term Neurocognitive Effects in Neonates Following Treatment with Lacosamide
dc.title.alternative2024.KAUM.IND.DCC
dspace.entity.typeStudy
local.admin.noteStudy PM: Ellen McQuaid, Study Analysts: Mitch Maltenfort https://atlassian.chop.edu/jira/browse/PMO-886
local.contributor.siteLeadPEDSnet Data Coordinating Center
local.contributor.sitesCincinnati Children�s Hospital Medical Center
local.contributor.sitesChildren�s Hospital of Philadelphia
local.contributor.sitesChildren�s National Hospital
local.contributor.sitesChildren�s Hospital Colorado
local.contributor.sitesAnn & Robert H. Lurie Children�s Hospital of Chicago
local.contributor.sitesNationwide Children�s Hospital
local.contributor.sitesSeattle Children�s Hospital
local.contributor.sitesStanford Children�s Health
local.contributor.sitesNemours Children�s Health
project.endDate2025
project.startDate2024
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