CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 303 enrolled
Drug / intervention
Surveys +1 moreother
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Neonates under 44 weeks corrected age at time of seizure onset
  • ✓Seizures attributed to acute brain injury
  • ✓Parent(s) English or Spanish literate (with interpreter assistance permitted)
Key exclusion· 4
  • ✕Neonates at risk for adverse outcome independent of seizures and underlying brain injury
  • ✕Neonates with mild, temporary causes for seizures
  • ✕Newborns with neonatal-onset epilepsy syndromes
  • ✕Neonates who do not survive the initial hospital admission

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02789176
NCT02789176N/ACompleted
CompareCT.gov

Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

University of Michigan·observational·Posted Jun 2, 2016·Updated Dec 4, 2020

In Brief

An observational study evaluating Surveys and EEG for Neonatal Seizures. Completed, enrolled 303 participants across 11 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Seizures
CountriesUnited States
CollaboratorsUniversity of California, San Francisco, Boston Children's Hospital, Children's Hospital of Philadelphia, Children's National Research Institute, Massachusetts General Hospital, Patient-Centered Outcomes Research Institute, Stanford University, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Duke University, Children's Hospital Medical Center, Cincinnati

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2, 2016
Enrollment StartOct 1, 2016
Primary CompletionMar 24, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.1 years ago

Interventions

Surveysother

Regarding development, epilepsy, and family impact

EEGother