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临床试验/NCT02658526
NCT02658526撤回不适用

Role of Anesthesia / Surgery on Cognitive Function in Child

Konstanze Plaschke1 个研究点 分布在 1 个国家开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Global cognitive abilities

研究概览

简要总结

The role of surgical stress and anesthesia is unknown in the early childhood. In vitro and animal studies showed a risk for treatment with anesthesia in the developmental brain. Furthermore, stress is also an important risk factor for cognitive impairment. Therefore, the investigators want to investigate in a clinical prospective cohort study the role anesthesia and surgery on different cognitive parameters and self-controling mechanisms in children under 3 years.

详细描述

In order to investigate the role of anesthesia and / or surgery on cognitive abilities the investigators want to perform a prospective cohort study in children under 3 years. Three groups should be compared: i) control without anesthesia / surgery, ii) children with only anesthesia, and iii) children with both surgery and anesthesia. All children will be investigate before and after intervention. Different behavioral scales will be used for detailed cognitive abilities and self-regulatory skills.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 9 month to 3 years with or without anesthesia / surgery

排除标准

  • Psychiatrical, neurological, oncological diseases

结局指标

主要结局

Global cognitive abilities

时间窗: 4-6 weeks

Early Childhood Behavior Questionnaire (ECBQ) questionnaire

次要结局

  • surgery-associated data(1 day)

研究者

发起方
Konstanze Plaschke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Konstanze Plaschke

Prof.

Heidelberg University

研究点 (1)

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