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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

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

Recruitment Status

Recruiting

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.

Eligibility Criteria

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 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

Gender

All

Min Age

2 Years

Max Age

8 Years

Download Date

August 14, 2023

Principal Investigator

N/A

Primary Contact Information

Hannah C. Glass, MDCM, MAS

415-476-3785

Hannah.glass@ucsf.edu

Yasmeen A. Rezaishad, BS

415-476-3785

Yasmeen.rezaishad@ucsf.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Neonatal Seizure Registry - Developmental Functional EValuation NCT04337697 Hannah C. Glass, MDCM, MAS 415-476-3785 Hannah.glass@ucsf.edu Yasmeen A. Rezaishad, BS 415-476-3785 Yasmeen.rezaishad@ucsf.edu