Registry studying genetics of epilepsy in children with neonatal seizures
Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy (NSR-GENE)
This study is trying to see how genetics affects the risk of developing epilepsy in children who had seizures shortly after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT05361070 on ClinicalTrials.gov |
What this trial studies
The NSR-GENE study is a longitudinal cohort study involving approximately 300 parent-child trios aimed at understanding how genetic factors influence the risk of developing post-neonatal epilepsy in children who have experienced acute provoked neonatal seizures. Researchers will collect clinical data, EEG, MRI, and genetic information to develop predictive models that categorize neonates into varying risk levels for post-neonatal epilepsy. This study seeks to enhance existing clinical risk factors by incorporating genetic insights, potentially leading to better management strategies for affected children.
Who should consider this trial
Good fit: Ideal candidates include children under 44 weeks postmenstrual age at seizure onset who have experienced acute provoked seizures due to conditions like hypoxic-ischemic encephalopathy or stroke.
Not a fit: Patients with transient causes for seizures or those with underlying conditions independent of seizures, such as inborn errors of metabolism or brain malformations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a predictive framework for identifying infants at high risk for developing epilepsy, allowing for earlier intervention and tailored treatment strategies.
How similar studies have performed: While the approach of integrating genetic factors with clinical data is innovative, similar studies have shown promise in understanding epilepsy risk, suggesting potential for success in this novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children \< 44 weeks postmenstrual age at seizure onset * Seizures due to an acute provoked cause (including, but not limited to HIE, ischemic stroke, or intracranial hemorrhage) * Parent(s) who are English or Spanish literate (with interpreter) * Birthdate between 3/1/2023 and 1/1/2011 * One biological parent willing to participate * Enrolled in NSR-II * Fulfilling all NSR-II eligibility criteria and evaluated at an NSR center for neonatal seizures or enrolled in NSR-RISE Exclusion Criteria: * 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., hypoglycemia without brain injury, hyponatremia, hypocalcemia) * Neonatal-onset epilepsy syndromes * Deceased
Where this trial is running
San Francisco, California and 7 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Children's National Medical Center — Washington, District of Columbia, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Hannah C Glass, MDCM, MAS — University of California, San Francisco
- Study coordinator: Hannah C Glass, MDCM, MAS
- Email: hannah.glass@ucsf.edu
- Phone: 415-476-3785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.