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:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6,000
- Locations
- 12
- Primary Endpoint
- 抽搐发作
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
Study Sites (12)
Loading locations...
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