Status:
COMPLETED
Neonatal Seizure Registry - Developmental Functional EValuation
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
University of Michigan
Stanford University
Conditions:
Neonatal Seizure
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
2-8 years
Brief Summary
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as exa...
Detailed Description
Neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical questi...
Eligibility Criteria
Inclusion
- Enrolled in NSR-II
- Alive at the start of the NSR-DEV study period
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
Exclusion
- Neonates who were found to have exclusion criteria after NSR-II enrollment
- 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., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
- Neonatal-onset epilepsy syndromes
Key Trial Info
Start Date :
March 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04337697
Start Date
March 15 2020
End Date
March 1 2025
Last Update
June 6 2025
Active Locations (9)
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1
University of California, San Francisco
San Francisco, California, United States, 94158
2
Stanford University
Stanford, California, United States, 94304
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114