Summary

Eligibility
for people ages 2-8 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Hannah C. Glass, MDCM, MAS
Photo of Hannah C. Glass
Hannah C. Glass

Description

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.

Details

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.

Keywords

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

Eligibility

You can join if…

Open to people ages 2-8

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • Stanford University accepting new patients
    Stanford California 94304 United States

Lead Scientist at UCSF

  • Hannah C. Glass, MDCM, MAS
    Dr. Hannah Glass is a pediatric neurologist, founding co-director of the Neurointensive Care Nursery (NICN), and Director of Neonatal Critical Care Services at the UCSF Benioff Children's Hospital. She is also the program director of the Neonatal Neurology Fellowship Program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04337697
Study Type
Observational [Patient Registry]
Last Updated