Status:
RECRUITING
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Neonatal Seizure
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
Brief Summary
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...
Detailed 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05361070
Start Date
August 9 2022
End Date
February 28 2027
Last Update
April 6 2025
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94158
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115