RECRUITING

Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The NSR-GENE study is a longitudinal cohort study of approximately 300 parent-child trios from the Neonatal Seizure Registry and participating site outpatient clinics that aims to evaluate whether and how genes alter the risk of post-neonatal epilepsy among children with acute provoked neonatal seizures. The researchers aim to develop prediction rules to stratify neonates into low, medium, and high risk for post-neonatal epilepsy based on clinical, electroencephalogram (EEG), magnetic resonance imaging (MRI), and genetic risk factors.

Official Title

Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy (NSR-GENE)

Quick Facts

Study Start:2022-08-09
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05361070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children \< 44 weeks postmenstrual age at seizure onset
  2. * Seizures due to an acute provoked cause (including, but not limited to HIE, ischemic stroke, or intracranial hemorrhage)
  3. * Parent(s) who are English or Spanish literate (with interpreter)
  4. * Birthdate between 3/1/2023 and 1/1/2011
  5. * One biological parent willing to participate
  6. * Enrolled in NSR-II
  7. * Fulfilling all NSR-II eligibility criteria and evaluated at an NSR center for neonatal seizures or enrolled in NSR-RISE
  1. * Risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to inborn errors of metabolism, fetal infection, brain malformation)
  2. * Transient cause for seizures (e.g., hypoglycemia without brain injury, hyponatremia, hypocalcemia)
  3. * Neonatal-onset epilepsy syndromes
  4. * Deceased

Contacts and Locations

Study Contact

Hannah C Glass, MDCM, MAS
CONTACT
415-476-3785
hannah.glass@ucsf.edu
Yasmeen A Rezaishad, BS
CONTACT
415-476-3785
yasmeen.rezaishad@ucsf.edu

Principal Investigator

Hannah C Glass, MDCM, MAS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94158
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Duke University
Durham, North Carolina, 27705
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Hannah C Glass, MDCM, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-09
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-08-09
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Neonatal Seizure
  • Hypoxic-Ischemic Encephalopathy
  • Stroke
  • Intracranial Hemorrhage
  • Epilepsy
  • Gene Abnormality