Neonatal Seizure Registry - Developmental Functional EValuation (NSR-DEV)

  • STATUS
    Recruiting
  • End date
    Feb 29, 2024
  • participants needed
    280
  • sponsor
    University of California, San Francisco
Updated on 4 October 2022
seizure
developmental disabilities
neonatal seizures
neonatal convulsions

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.

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.

Details
Condition Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages, Epilepsy, Cerebral Palsy, Intellectual Disability
Clinical Study IdentifierNCT04337697
SponsorUniversity of California, San Francisco
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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