Neonatal Seizure Registry - Developmental Functional EValuation

NCT04337697 | Completed

• 3 other identifiers: 19-285841R01NS111166-01A1R01NS111166
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 9

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 examine risk factors for developmental disabilities and whether these are modified by parent well-being.

Conditions

Stroke; Intracranial Hemorrhages; Epilepsy; Cerebral Palsy; Intellectual Disability; Neonatal Seizure; Hypoxic-Ischemic Encephalopathy

Keywords

Family impact; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (47)

• 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

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient, family members/caregivers, providers, children/minors, subjects unable to read, speak or understand English

You may qualify if:

• 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)

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., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
• Neonatal-onset epilepsy syndromes

Sponsors & Collaborators

• University of Michigan: collaborator
• Stanford University: collaborator
• Duke University: collaborator
• Boston Children's Hospital: collaborator
• Children's National Research Institute: collaborator
• Massachusetts General Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of California, San Francisco: lead

Study Sites (9)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 40510235 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Stroke; Intracranial Hemorrhages; Epilepsy; Cerebral Palsy; Intellectual Disability

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Brain Damage, Chronic; Neurobehavioral Manifestations; Neurologic Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hannah C. Glass, MDCM, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 8, 2020
• Study Start: March 15, 2020
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: In accordance with study sponsor
• Access Criteria: In accordance with study sponsor

Locations

US (9)