NCT04337697|Completed
Neonatal Seizure Registry - Developmental Functional EValuation
NSR-DEV
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NSR-DEV
Sponsor study identifier
Secondary identifiers
observational
188
1 country
9
Study Start
March 15, 2020
Actual (reported)Primary Completion
February 28, 2025
Actual (reported)Study Completion
March 1, 2025
Actual (reported)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 examine risk factors for developmental disabilities and whether these are modified by parent well-being.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2020
Actual (reported)March 31, 2020
Actual (reported)April 8, 2020
Actual (reported)February 28, 2025
Actual (reported)March 1, 2025
Actual (reported)Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)
The WPPSI-IV is an in-person assessment administered by a psychologist or psychometrician that will be used to measure neurocognitive ability. Full Scale IQ (FSIQ) will be generated for each participant from the following subtests: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Fluid Reasoning Index (FRI), Working Memory Index (WMI), Processing Speed Index (PSI), Receptive Vocabulary and Picture Naming.
At age 5.5 years during in-person study visit
Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition
At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8
Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English
University of California, San Francisco
San Francisco, California, 94158, United States
Stanford University
Stanford, California, 94304, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Duke University
Durham, North Carolina, 27705, United States
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.
Hannah C. Glass, MDCM, MAS
University of California, San Francisco
188 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2020
First Posted
April 8, 2020
Study Start
March 15, 2020
Actual (reported)Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)
At enrollment study visit
Scores for each child on Behavior Rating Inventory of Executive Function®, Preschool version (BRIEF-P)
At age 5.5 years during in-person study visit
Scores for each child on The Social Responsiveness Scale, 2nd edition (SRS-2) - Parent Form
At enrollment study visit
Contact the study team to confirm eligibility.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Primary Completion
February 28, 2025
Actual (reported)Study Completion
March 1, 2025
Actual (reported)Last Updated
February 5, 2026
Record last verified: 2026-02
In accordance with study sponsor
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Source: ClinicalTrials.gov.
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