Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
NCT ID: NCT02789176
Last Updated: 2020-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
303 participants
OBSERVATIONAL
2016-10-31
2020-03-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Outpatient Enrollees
This is a cohort of 150 subjects who were previously enrolled in the Neonatal Seizure Registry, a multi-center association of institutions across the United States, They were contacted to participate in the study after discharge from the Neonatal Intensive Care Unit (NICU) but prior to the prospective follow up. They were asked to take part in all prospective follow up surveys at 12, 18, \& 24 months of age.
Surveys
Regarding development, epilepsy, and family impact
NICU Enrollees
This is a cohort of 150 subjects who were enrolled in the study prior to discharge from the NICU. They were asked to complete surveys prior to discharge from the NICU, returned to the hospital for a 1 hour EEG to monitor brain activity between 2-4 months of age, \& completed the follow surveys at 12, 18, \& 24 months of age.
Surveys
Regarding development, epilepsy, and family impact
EEG
Interventions
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Surveys
Regarding development, epilepsy, and family impact
EEG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Seizures due to acute brain injury
* Parent(s) who are English or Spanish literate (with assistance of interpreter)
Exclusion Criteria
* Neonates with mild, temporary causes for seizures
* Newborns with neonatal-onset epilepsy syndromes
* Neonates who do not survive the initial hospital admission
* Neonates will not be excluded based on race, ethnicity, gender or gestational age
0 Weeks
24 Months
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Boston Children's Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Children's National Research Institute
OTHER
Massachusetts General Hospital
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Stanford University
OTHER
Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Duke University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Michigan
OTHER
Responsible Party
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Renée Shellhaas, MD
Clinical Professor
Principal Investigators
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Renée A Shellhaas, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Hannah C Glass, MDCM, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Franck LS, Shellhaas RA, Lemmon M, Sturza J, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Thomas C, Rogers EE, McCulloch CE, Grant K, Grossbauer L, Pawlowski K, Glass HC; Neonatal Seizure Registry study group. Associations between Infant and Parent Characteristics and Measures of Family Well-Being in Neonates with Seizures: A Cohort Study. J Pediatr. 2020 Jun;221:64-71.e4. doi: 10.1016/j.jpeds.2020.02.024.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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1507-31187
Identifier Type: OTHER
Identifier Source: secondary_id
HUM00114541
Identifier Type: -
Identifier Source: org_study_id