NCT04337697

Neonatal Seizure Registry - Developmental Functional EValuation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 188 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2020-03-15
• Primary completion: 2025-02-28
• Completion: 2025-03-01
• First posted: 2020-04-08
• Last updated: 2026-02-05

Locations

9 sites across 1 country: United States