Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy (NSR-GENE)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Neonatal Seizure
Epilepsy
Intracranial Hemorrhage
Stroke
Gene Abnormality
Hypoxic-Ischemic Encephalopathy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05361070
R01NS124051 (U.S. NIH Grant/Contract)
R01NS124051-01A1 (U.S. NIH Grant/Contract)
21-35563

Details and patient eligibility

About

The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.

Full description

Neonatal seizures due to brain injury (acute provoked seizures) are associated with high risk of post-neonatal epilepsy. Although clinical risk factors can help predict which children are at highest risk for epilepsy, little is known about how genetic factors modify the risk for epilepsy after acute provoked neonatal seizures. The Neonatal Seizure Registry - GENetics of Epilepsy (NSR-GENE) study will test the central hypothesis that children who develop post-neonatal epilepsy are more likely to have pathogenic variants in epilepsy genes, and enrichment in single nucleotide polymorphisms within key inflammatory, neurotransmitter transport and homeostasis, and neurotrophic gene pathways as compared with children who do not develop unprovoked seizures before age five years, and that these can be added to traditional clinical risk factors to predict epilepsy after neonatal seizures.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children < 44 weeks postmenstrual age at seizure onset
  • Seizures due to an acute provoked cause (including, but not limited to HIE, ischemic stroke, or intracranial hemorrhage)
  • Parent(s) who are English or Spanish literate (with interpreter)
  • Birthdate between 3/1/2023 and 1/1/2011
  • One biological parent willing to participate
  • Enrolled in NSR-II
  • Fulfilling all NSR-II eligibility criteria and evaluated at an NSR center for neonatal seizures or enrolled in NSR-RISE

Exclusion criteria

  • Risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to inborn errors of metabolism, fetal infection, brain malformation)
  • Transient cause for seizures (e.g., hypoglycemia without brain injury, hyponatremia, hypocalcemia)
  • Neonatal-onset epilepsy syndromes
  • Deceased

Trial contacts and locations

8

Loading...

Central trial contact

Hannah C Glass, MDCM, MAS; Yasmeen A Rezaishad, BS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems