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Clinical Trials/ChiCTR1800016975
ChiCTR1800016975Active, not recruitingNot Applicable

儿童热性惊厥的短程预防-----前瞻性多中心“真实世界研究”

医疗必需项目患者自费12 sites in 1 country6,000 target enrollmentStarted: July 5, 2018Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
6,000
Locations
12
Primary Endpoint
抽搐发作
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

本试验为前瞻性、多中心，真实世界试验，致力研究儿童热性惊厥预防性治疗的最佳方案。

Study Design

Study Type
观察性研究
Primary Purpose
队列研究
Masking
N/a

Eligibility Criteria

Ages
1 to 6 (—)
Sex
All

Inclusion Criteria

  • •1）年龄及初次发作在 6 个月至 5 岁之间的儿童；
  • •2）发热状态下（腋温≥38℃，肛温≥38.5℃）出现惊厥发作；
  • •同意按照试验方案的要求配合用药和接受评估；
  • •4）儿童作为受试者，必须征得其法定监护人的知情同意并自愿签署知情同意书。

Exclusion Criteria

  • •1）既往有癫痫病史者因感染诱发惊厥发作；
  • •2）中枢神经系统感染；
  • •5）急性中毒或遗传代谢性疾病所致的惊厥；
  • •6）既往有无热惊厥病史；
  • •7）明确的对试验药品或其制剂成份过敏者；

Arms & Interventions

空白对照组

无干预措施

地西泮组

于发热初期予口服地西泮预防热性惊厥（地西泮剂量：0.3mg/kg，最大剂量不超过 10mg，发热 24 小时内每 8 小时 1 次，≤3 次）

左乙拉西坦组

首次发作后予左乙拉西坦口服 15-30mg/(kg.d)，分两次，连续口服 5 天。

Outcomes

Primary Outcomes

抽搐发作

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
医疗必需项目患者自费

Study Sites (12)

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