Comparison of 4 Weeks Versus 12 Weeks Anti-convulsant Therapy for Acute Symptomatic Seizure in Children With Acute Encephalitis Syndrome- Open Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Seizure relapse rate
研究概览
简要总结
There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections
详细描述
Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups.
Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)
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
- None
盲法说明
Open label study
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness
排除标准
- •Children with chronic meningitis, brain abscess, intracranial Space occupying lesion
- •Children with prior history of seizures, prior focal neurological deficit
- •Children with abnormal development prior to development of seizures
- •HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy
- •Children on two or more than 2 anti-epileptic drugs
- •Severely affected children (Pediatric Cerebral Performance Category Scale (PCPC) Score, Pediatric Overall Performance Category Scale with category score of 5)
- •Refusal of consent
研究组 & 干预措施
Group 4 weeks
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
干预措施: Group 4 weeks (Other)
Group 12 weeks
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
干预措施: Group 12 weeks (Other)
结局指标
主要结局
Seizure relapse rate
时间窗: 6 months
Seizure relapse rate (proportion of participants) developing seizures after randomization
次要结局
- Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence(6 months)
- Seizure relapse rate(24 months)
- Factors associated with seizure recurrence(6 months)
研究者
Dhawan Sumeet Rajendra
Senior Resident, Department of Pediatrics
Post Graduate Institute of Medical Education and Research, Chandigarh