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临床试验/NCT03034889
NCT03034889已完成不适用

Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
试验地点
1
主要终点
Cognitive Capacity for children between 7 and 10 years of age

研究概览

简要总结

The infantile brain has to pass essential, mayor steps in the first 36 months of life. During that period of development it is particularly vulnerable to toxic, exogenic influences. This study wants to review the long-term effects of children who were exposed to anesthesia in the first three years of their life. Therefore the investigators will examine children at age of 4-10 that were exposed to anesthesia and compare their neurocognitive capacity to children who did not have any exposure to anesthesia. The investigators plan on measuring the intelligence quotient using standardized tests which will be performed by a trained psychologist. In addition there will be a questionnaire concerning behavioral characteristics and educational development which is filled by the parents. The exposed children will be recruited from our preexisting database, the control group will be recruited from practitioners and the pediatric walk-in-clinic.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • General anesthesia before the age of 36 months

排除标准

  • neurosurgical interventions
  • cardiac surgery
  • preexisting hereditary or acquired cognitive deficits
  • no informed consent

结局指标

主要结局

Cognitive Capacity for children between 7 and 10 years of age

时间窗: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

Standardized tests for intelligence quotient (IQ): Kaufman Assessment Battery for Children - Second Edition (KABC-II)

Cognitive Capacity for children between 2 and 4 years of age

时间窗: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

Standardized tests for intelligence quotient (IQ): Wechsler Intelligence Scale for Children (WISC-IV)

Cognitive Capacity for children between 4 and 7 years of age

时间窗: Test is done 1 to 10 years after anesthesia and is lasting 3 hours

Standardized tests for intelligence quotient (IQ): Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)

次要结局

  • Educational status(1 to 10 years after anesthesia, lasting 30 minutes)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tino Münster

Prof. Dr.

University of Erlangen-Nürnberg Medical School

研究点 (1)

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