A RANDOMIZED CONTROLLED TRIAL OF LEVETIRACETAM VERSUS PHENOBARBITONE FOR TREATMENT OF NEONATAL SEIZURE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of Levetiracetam versus Phenobarbitone in controlling neonatal seizures.
研究概览
简要总结
Phenobarbitone is the drug of choice for neonatal seizures irrespective of the cause of seizures. But the adverse effects of Phenobarbitone on developing brain are well established. So there is a dire need for a newer and safer alternative to Phenobarbitone.
Levetiracetam is a relatively newer antiepileptic drug. Studies in elder children and adults have shown some promising results. But the studies pertaining to its use in neonatal seizures is rather limited. Few randomized controlled trials show the superiority of Levetiracetam over Phenobarbitone. But the numbers of randomized controlled trials are very much limited.
We aim to conduct this study with the objective to compare the efficacy and safety of Levetiracetam versus Phenobarbitone in the treatment of neonatal seizures.
Keywords: Neonatal seizures, Phenobarbitone, Levetiracetam
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All inborn and outborn neonates (age 0-28 days) between 35 weeks to 42 weeks of gestational age admitted in NICU with clinical seizures will be enrolled in the study.
- •For this study we will be considering subtle seizure, tonic seizures, clonic seizures and myoclonic seizures.
排除标准
- •Major congenital malformation --Need for assisted ventilation at the time of admission --Refractory shock --Serum creatinine >2 mg/dl --Anticonvulsant prior to admission --Neonates with hypoglycaemia, hypocalcemia or hypo / hyperkalemia.
结局指标
主要结局
To evaluate efficacy of Levetiracetam versus Phenobarbitone in controlling neonatal seizures.
时间窗: Whether seizure is controlled within 1 hour or not. | And time taken for clinical control of seizure.
次要结局
- Recurrence of seizure(Within 24 hours of administration of the 1st or 2nd loading dose.)
- Adverse effect: Respiratory depression / Apnoea / Desaturation(Within 8 hours of administration of drug)
- Duration of hospitalization(Number of days child was admitted in NICU)
- Adverse effect: Heart rate fluctuations(Within 8 hours of administration of drug)