CTRI/2020/04/024952尚未招募1 期
Efficacy of Levetiracetam versusPhenobarbitone in the control of neonatal seizures in asphyxiated newborns as first line therapy: a randomised controlled trial
Department of neonatology and pediatrics1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical and electrical control (using aEEG) of seizure activity in the neonates within one hour of loading with the drug and no recurrence for the next 24 hours.
研究概览
简要总结
This study is an open labe RCT, which will be done in department of neonatology and pediatrics PGIMS Rohtak to compare the efficacy of levetiracetam and phenobarbitone in the control of neonatal seizures due to perinatal asphyxia. Continuous EEG monitoring will be done to detect subclinical cassestion of seizures and at the same time adverse effects of both the drugs will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Full termGestational age more than equal to 37 weeks Birth weight more than or equal to2 kgs Perinatal asphyxia defined as:APGAR score less than 5 at 5 minutes, Cord pH less than 7.0, Base deficit more than12 : in deliveries attended by the pediatrician at the hospital ,Delayed onset of cry after 3 min of birth in deliveries not attended by doctor or at home.
- •HIE with clinical seizures : onset within 24 hours of life Inborn neonates admitted on day one of life.
排除标准
- •Anticonvulsant prior to admission Neonatal seizures due to proven metabolic causes: hypoglycemia, hypocalcaemia, etc.
- •Neonates who are treated with therapeutic hypothermia Serum creatinine levels > 1.5mg/dl Gross congenital malformations TORCH infections.
结局指标
主要结局
Clinical and electrical control (using aEEG) of seizure activity in the neonates within one hour of loading with the drug and no recurrence for the next 24 hours.
时间窗: 1 day
次要结局
- Short term toxicity of levetiracetam will be monitored:Apnea within 4 hour period following Levetiracetam infusion,Anaphylactic shock occurring following the levetiracetam infusion, toxic epidermic necrosis Steven Johnson syndrome,Serum creatinine levels(2.Any adverse effects with phenobarbitone will be monitored: Irritability, Sedation, Hypotension,Respiratory suppression,hepatotoxicity)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A study to control the effectiveness of two drugs, which are phenobarbitone (used for seizures in first 28 days of life) and levetiracetam ( new drug for seizures) in newborns who have seizures in the first 24 hours of life with delayed cry at birth.CTRI/2020/04/024952Department of neonatology and pediatrics
招募中
3 期
comparison of levetiracetam with phenobarbitone in neonatal seizureCTRI/2013/01/00331080
招募中
Phase 3 4
Levetiracetam for management of seizures in newbornCTRI/2013/04/003585Rainbow Childrens Hospital100
已完成
2 期
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status EpilepticusGrand Mal Status EpilepticusNCT02920060Banaras Hindu University80
招募中
4 期
Comparision between phenobarbitone and levetiracetam as the intial anti convulsant in treating preterm neonatal seizuresCTRI/2021/02/031290Gummalla Gyandeep106