Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy

Running, not enrolling

Conditions studied: Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhage, Epilepsy, Gene Abnormality

In brief

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.

Key facts

Study ID

NCT05361070

Run by

University of California, San Francisco

People needed

300

Starts

2022-08-09

Expected to finish

2027-02-28

Last updated by the study team

2026-02-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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