Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures (NCT04320940) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Stopped: Insufficient participant recruitment hindered the study's progress, preventing robust data collection and compromising statistical power
United States, Jordan4 participantsStarted 2021-03-12
Plain-language 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.
Who can participate
Age range
34 Weeks – 44 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)
* Parental informed consent (in-person or remote consent)
* Undergoing continuous video electroencephalogram (cvEEG) monitoring
* Has evidence of electrographic seizure burden of at least 30 seconds/h
Exclusion Criteria:
* Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation \> 24 hours before enrollment)
* Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization
* Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder
* Death appears to be imminent as assessed by the NICU attending physician
* Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.