Neonatal Seizure Registry - Developmental Functional EValuation — NSR-DEV  

Stroke Clinical Trial

Official title: Neonatal Seizure Registry - Developmental Functional EValuation

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cerebral Palsy
• Epilepsy
• Hemorrhage
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Intellectual Disability
• Intracranial Hemorrhages
• Neonatal Seizure
• Seizures
• Stroke

• NCT number: NCT04337697
• Study type: Observational [Patient Registry]
• Source: University of California, San Francisco
• Contact: Hannah C. Glass, MDCM, MAS
• Phone: 415-476-3785
• Email: Hannah.glass@ucsf.edu
• Status: Recruiting
• Start date: March 15, 2020
• Completion date: February 29, 2024