Purpose

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

Eligibility

Eligible Ages
Between 2 Years and 8 Years
Eligible Genders
All
Accepts 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 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010
Contact:
Ruoying (Penny) Li
202-476-3807
rli@childrensnational.org

More Details

NCT ID
NCT04337697
Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Hannah C. Glass, MDCM, MAS
415-476-3785
Hannah.glass@ucsf.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.