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NCT02789176 · ClinicalTrials.gov registry record
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
A clinical trial of Neonatal Seizures, sponsored by University of Michigan.
- Completed
- Registry status
- 303
- Enrollment target
- 11
- Study locations
NCT02789176: Completed study of Neonatal Seizures, sponsored by University of Michigan.
NCT02789176 is a study of Neonatal Seizures that has completed, run by University of Michigan. The registered enrollment target is 303 participants. The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02789176, a study of Neonatal Seizures, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 303 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.
Primary Outcome
The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA FS) allowed us to compare the functional development between newborns who received short duration phenobarbital treatment and prolonged phenobarbital treatment. There were 50 questions with response options of 1(Never) to 4(all the time). WIDEA range was on a scale from 50-200 (At 24 months, the normal population mean score is 172±10).The higher the score the better the child's developmental function. Mean score
Conditions Studied
Interventions
- OTHER Surveys
- OTHER EEG
Study Locations (11)
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
California
- University of California, San Francisco - San Francisco
- Stanford University - Stanford
District of Columbia
- Children's National Medical Center - Washington D.C.
Michigan
- University of Michigan - Ann Arbor
North Carolina
- Duke University - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2016-10 |
| Est. Completion | 2020-03-24 |
What the finished NCT02789176 record still lists
NCT02789176 is an observational study that tracks outcomes without assigning an intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Neonatal Seizures appearing as the primary indexed condition, and to 2 interventions - of which Surveys is the first listed.
NCT02789176 lists 11 locations in 7 states (Massachusetts, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT02789176 about?
NCT02789176 is a clinical study titled "Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study". The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.
What is the current status of trial NCT02789176?
This trial is currently completed. The enrollment target is 303 participants. The study started on 2016-10. Estimated completion is 2020-03-24.
What conditions does trial NCT02789176 study?
This clinical trial studies the following conditions: Neonatal Seizures.
What interventions are being tested in trial NCT02789176?
The interventions under investigation include: Surveys (OTHER), EEG (OTHER).
Who is sponsoring clinical trial NCT02789176?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02789176 being conducted?
This trial has 11 study locations across California, District of Columbia, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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