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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose.
Arkansas Cildren's Hospital
Little Rock, Arkansas, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
South Miami Hospital
Miami, Florida, United States
Jamie Flores-Torres
Tampa, Florida, United States
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.
Time frame: 24 hours
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
Percent of neonates who do not require additional seizure treatment after 2 hours of the first dose of phenobarbital.
Time frame: 2 hours
Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.
Percent of neonates who do not require additional seizure treatment after the second dose of phenobarbital within the first 24 hours of treatment.
Time frame: 24 hours
Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.
Number of subject required monitoring of seizure burden over 48 hours following initial administration of the phenobarbital injection.
Time frame: 48 hours
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Matthew Butoryak
Pittsburgh, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Marshall Health
Huntington, West Virginia, United States
Jordan University of Science and Technology (King Abdullah University Hospital, KAUH)
Irbid, Jordan