Neonatal Seizure Registry - Developmental Functional EValuation

Active, not recruiting

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

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.

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 question for parents and providers, outcomes beyond infancy are largely unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)	At age 5.5 years during in-person study visit	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.

Secondary Outcome Measures

Name	Time	Method
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	The Vineland Adaptive Behavior Scales Parent Form measures adaptive behavior and intellectual and developmental function. Adaptive behavior is predictive of functional performance in school and is linked to both cognitive and executive function. Scores for each participant at each timepoint are generated based on parent reports in the following categories: Communication, Daily Living Skills, Socialization, Motor Skills, Adaptive Behavior Composite (ABC). We will look at the change in score over time for each participant during the study period after the Vineland-3 is administered at each timepoint.

Locations (9): Stanford University
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Stanford, California, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
University of Michigan
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Ann Arbor, Michigan, United States
Duke University
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Durham, North Carolina, United States
Boston Children's Hospital
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Boston, Massachusetts, United States
Children's National Medical Center
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Washington, District of Columbia, United States
University of California, San Francisco
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San Francisco, California, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States