Stopped: Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Timeframe: 24 hours