Neonatal Seizure Registry - Developmental Functional EValuation
NCT ID: NCT04337697
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
188 participants
OBSERVATIONAL
2020-03-15
2025-03-01
Brief Summary
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Detailed Description
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The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants enrolled at one of nine sites across the USA. Participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Alive at the start of the NSR-DEV study period
* Parent(s) who are English or Spanish literate (with assistance of interpreter)
Exclusion Criteria
* Transient cause for seizures (e.g., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
* Neonatal-onset epilepsy syndromes
2 Years
8 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Stanford University
OTHER
Duke University
OTHER
Boston Children's Hospital
OTHER
Children's National Research Institute
OTHER
Massachusetts General Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Hannah C. Glass, MDCM, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, 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
Countries
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References
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Franck LS, Lemmon ME, Grossbauer L, Pawlowski K, Sturza JS, Wusthoff CJ, Massey SL, Chu CJ, Soul JS, Numis AL, Thomas C, Benedetti GM, Anwar T, Berl MM, Gidley Larson JC, Rogers EE, Chen C, McCulloch CE, Glass HC, Shellhaas RA. Parent and Family Well-Being and Associated Risk Factors as Children with Neonatal Seizures Reach Preschool and School-Age: A Longitudinal Cohort Study. J Pediatr Clin Pract. 2025 May 16;16:200149. doi: 10.1016/j.jpedcp.2025.200149. eCollection 2025 Jun.
Other Identifiers
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