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临床试验/CTRI/2024/05/067855
CTRI/2024/05/067855尚未招募Phase 3 4

Role of prophylactic Levetiracetam on seizure prevention in children during post CPR recovery phase -A Randomized(Double Blinded)Controlled Trial

All India Institute of Medical Sciences Raipur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
50
试验地点
1
主要终点
occurence of seizures

研究概览

简要总结

The children between 1-month to ≤ 15 years of age, who have undergone CPR will be considered for the study. Hemodynamic stability would be achieved and patient details, course cause for cardio-pulmonary arrest will be documented. The participants will be randomized into two groups based on the computer-generated process i.e., prophylactic and the conventional group. The children in the prophylactic group will be started on antiepileptic medication which will be pre-labelled as drug X or Y and the principal investigator will be blinded from the drugused. Inj. Levetiracetam 40mg/kg/dose and followed by 20mg/kg/day in two divided doses within 30 minutes after hemodynamic stabilization and the children in the conventional group would be given equal volume of saline. The participants will be closely monitored for 7 days via EEG (electroencephalogram) and antiepileptic medication other than Levetiracetam will be initiated if they develop any clinical or non-clinical seizures as per physician discretion. The nursing staff will be taught and informed about giving drug X and drug Y in both the groups. Both the medications pre-labelled as X and Y required for study will be prepared apriori from the hospital pharmacy. If the patient doesn’t meet the inclusion criteria they would be excluded. If the child survives up to discharge, will be followed up after 30 days and 90 days.After the study is complete, the data will be recorded in Excel sheet and analysis will be performed using intention to treat process using latest SPSS version.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Month(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • All children between age of 1 month to 15 years who had cardiac arrest and undergone CPR after Return Of Spontaneous Circulation (ROSC) with hemodynamic stability.

排除标准

  • Brain dead children 2) The children with known seizure disorder on antiepileptic medications.

结局指标

主要结局

occurence of seizures

时间窗: during post CPR recovery phase till discharge from hospital

次要结局

  • Seizure pattern, duration of encephalopathy,organ dysfunction ,mortality and morbidity(till discharge)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Raju S M

All India Institute Of Medical Sciences,Raipur

研究点 (1)

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