Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
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.