Efficacy of Intravenous Levetiracetam in Neonatal Seizures: A Phase 2 Randomized Blinded Controlled Study of the Efficacy of Intravenous Levetiracetam (LEV) as First Line Treatment for Neonatal Seizures
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)
研究概览
简要总结
A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.
Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.
详细描述
This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects.
Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age.
This study aims to obtain essential data regarding the efficacy and safety of LEV in this vulnerable and under researched population and simultaneously to develop EEG monitoring systems that facilitate seizure detection and research.
Specific aims are:
- To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy.
- To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.
- To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
- To obtain further safety data of LEV in neonates.
- To prove the feasibility of centralized remote monitoring of continuous EEG monitoring in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising automated neonatal seizure detection algorithm.
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
- 15 Minutes 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to any of the study sites with electrographic seizures seizures.
- •Term infants gestational age >36 weeks less than 2 weeks of age.
- •Greater than 2200 grams.
- •Infants for whom parental consent to participate in the study is obtained.
排除标准
- •Infants who are already receiving anticonvulsants
- •If serum creatinine is greater than 1.6mM
- •If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)
- •Subjects in whom death seems imminent, as assessed by the neonatologist.
研究组 & 干预措施
Intravenous levetiracetam
Intravenous levetiracetam 40 to 60 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
干预措施: Intravenous levetiracetam (Drug)
Intravenous phenobarbital
Intravenous phenobarbital 20 to 40 mg/kg load. 1.5 mg/kg 8 hourly maintenance
干预措施: Intravenous phenobarbital (Drug)
结局指标
主要结局
Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)
时间窗: 24 hours
A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures. Seizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists.
次要结局
- Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment(48 hours)
- Number of Neonates With Seizure Termination at 1 Hour After Treatment(1 hour)
- LEV Dose Escalation Component(24 hours)
- Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia(24 hours)
研究者
Richard H. Haas
Professor
University of California, San Diego