Levetiracetam Treatment of Neonatal Seizures: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Oral Levetiracetam as First Line Treatment for Neonatal Seizures in China
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG
研究概览
简要总结
Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.
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 has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research.
Specific aims are:
- To determine the efficacy of oral Levetiracetam in terminating neonatal seizures by EEG in the Neonatal Neurological Intensive Care Unit (NNICU).
- To determine dose escalation data by studying the additional efficacy of a further dose in non responders.
- To determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
- To determine further safety data of oral Levetiracetam in neonates.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :
- •Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days
- •Birthweight >2500g
- •Written informed consent of parent or guardian
排除标准
- •Babies who have been close to death
- •Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder)
- •Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization
- •Abnormal renal function
研究组 & 干预措施
Oral levetiracetam
Oral levetiracetam 50 mg/kg loading dose. 10 mg/kg 8 hourly maintenance
干预措施: Oral levetiracetam (Drug)
Intravenous phenobarbital
Intravenous phenobarbital 20 loading dose (add to 40 mg/kg if seizure discontrol). 5 mg/kg 24 hourly maintenance
干预措施: Intravenous phenobarbital (Drug)
结局指标
主要结局
EEG
时间窗: At Day 28
Efficacy of levetiracetam by assessment of the change from baseline in EEG on Day 15.
次要结局
- Seizure Control Days(From Day 1 to Day 28 post-dose in each period)
- Number of Adverse Events(Respiratory)(From Day 1 to Day 28 post-dose in each period)
- Brain Parenchyma Alterations(MRI)(At Day 28)
- Neurodevelopment(Bayley Scores)(At Day 28)
- Number of Adverse Events(Pulse)(From Day 1 to Day 28 post-dose in each period)
- Number of Abnormal Clinical Urinalysis(From Day 1 to Day 28 post-dose in each period)
- Number of Adverse Events（Abnormal Appearance）(From Day 1 to Day 28 post-dose in each period)
- Number of Adverse Events（Abnormal Blood Pressure）(From Day 1 to Day 28 post-dose in each period)
- Number of Abnormal Hematology(From Day 1 to Day 28 post-dose in each period)
- Number of Abnormal Clinical Chemistry(From Day 1 to Day 28 post-dose in each period)