Cerebral Palsy, Epilepsy, Hypoxic-Ischemic Encephalopathy, Intellectual Disability, Intracranial Hemorrhages, Neonatal Seizure, Stroke
Conditions
Keywords
Family impact, Neurodevelopment
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.
Interventions
None listed
Sponsors
University of California, San Francisco
University of Michigan
Stanford University
Duke University
Boston Children's Hospital
Children's National Research Institute
Massachusetts General Hospital
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Neonates who were found to have
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHannah C. Glass, MDCM, MAS
University of California, San Francisco
Outcome results
None listed