A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 8
- 主要终点
- Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 34 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Phenobarbital Sodium Injection 20mg
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).
干预措施: Phenobarbital Sodium Injection (Drug)
Phenobarbital Sodium Injection 40mg
Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).
干预措施: Phenobarbital Sodium Injection (Drug)
结局指标
主要结局
Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
时间窗: 24 hours
Percent of neonates who do not require additional seizure treatment after the first dose of phenobarbital during the first 24 hours after treatment.
次要结局
- Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.(24 hours)
- Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.(2 hours)
- Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.(48 hours)