N/A N=303

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

Neonatal Seizures

Bottom Line

View on ClinicalTrials.gov: NCT02789176 ↗

Enrolled (actual)

303

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: WIDEA Neurodevelopmental Outcome Score — 149.04; 162.46; 148.80; 151.89 score on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Surveys (Other); EEG (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2020

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	—

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.

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

View full record on ClinicalTrials.gov →

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.