Efficacy of Levetiracetam in Control of Neonatal Seizures
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.
研究概览
简要总结
Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile.
Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012.
The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All full term neonates experiencing seizures due to; post-hypoxic or post-ischemic encephalopathy, intracerebral hemorrhage, cerebral infection, inborn errors of metabolism or malformations of cortical development
排除标准
- •Preterm neonates
- •Full term neonates with seizures due to metabolic derangements (hypoglycemia, hypocalcemia or hypomagnesemia)
- •Full term neonates with impaired renal functions.
研究组 & 干预措施
Levetiracetam
Levetiracetam given in oral form via oro-gastric tube, first a bolus dose 40-50mg/kg then maintenance dose 10-30 mg/kg/day divided every 12 hours.
Duration: until seizure free
干预措施: Levetiracetam (Drug)
Phenobarbital
Phenobarbital given in IV form, loading dose 20mg/kg that can be repeated after a 20 minute interval not to exceed 40mg/kg then maintenance dose 2-4 mg/kg/day divided every 12 hours.
Duration: until seizure free
干预措施: Phenobarbital (Drug)
结局指标
主要结局
Efficacy of levetiracetam in control of neonatal seizures as a first line versus phenobarbital through assessment of seizure burden.
时间窗: 72 hours
Number of seizures before and after levetiracetam administration in comparison to phenobarbital.
Efficacy of levetiracetam in rapid control of neonatal seizures compared to phenobarbital.
时间窗: 72 hours
Number of hours taken to achieve seizure freedom after administration of levetiracetam versus phenobarbital.
次要结局
- Dose escalation data about levetiracetam through studying the efficacy of further dose administration in non responders.(72 hours)
- Adequacy of levetiracetam as a single agent antiepileptic drug in control of neonatal seizures.(30 days)
- Accuracy of amplitude integrated EEG monitoring in detecting neonatal seizures before and after antiepileptic drug use.(48 hours)
- Effect of levetiracetam on aEEG background activity of participants.(48 hours)
- The short term clinical outcome of patients with neonatal seizures after treatment with levetiracetam.(3 months)
- The short term electroencephalographic outcome of patients with neonatal seizures after treatment with levetiracetam(3 months)
研究者
Yara Salah Shaheen
Pricipal Investigator
Cairo University