Neurocognitive Development in Children Who Received General Anesthesia Before the Age of 3 Years: A Historic-prospective, Controlled, Single Center Cross-section Trial
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
- 是
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
Tino Münster
Prof. Dr.
University of Erlangen-Nürnberg Medical School
