N/A
Completed N=303
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
Neonatal Seizures
Source: ClinicalTrials.gov NCT02789176 ↗
Enrolled (actual)
303
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: WIDEA Neurodevelopmental Outcome Score — 149.04; 162.46; 148.80; 151.89 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WIDEA Neurodevelopmental Outcome Score |
149.04; 162.46; 148.80; 151.89 | — |
| PRIMARY Number of Participants With Post-neonatal Epilepsy |
14; 2; 11; 10 | — |
| SECONDARY Length of Stay for the Neonatal Seizure Admission |
15; 11; 17; 15 | — |
| SECONDARY Impact of Treatment Duration on Parent and Family Well-being |
3.44; 2.92; 3.17; 3.72; 6.15; 5.30 | — |
Eligibility Criteria
Inclusion Criteria
- Neonates <44 weeks corrected age at seizure onset
- Seizures due to acute brain injury
- Parent(s) who are English or Spanish literate (with assistance of interpreter)
Exclusion Criteria
- 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
- Neonates will not be excluded based on race, ethnicity, gender or gestational age
Data sourced from ClinicalTrials.gov (NCT02789176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.