General Anesthesia Exposed Infants Neurodevelopment Investigation: a Multi-center Prospective Cohort Study United in Shanghai
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change of the developmental quotient of the Gesell Developmental Inventory
研究概览
简要总结
Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.
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
- 4 Weeks 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apgar score ≥ 8 at birth
- •ASA level Ⅰ~Ⅲ
- •Obtained written consent form from the infants' parents or guardians
排除标准
- •Postmenstrual age ≤ 44 weeks, or postmenstrual age ≥ 144 weeks
- •Severe cardiac, pulmonary, or neurologic disease
- •Severe obstructive sleep apnea hypopnea syndrome
- •History of dystocia and/or hypoxic ischemic encephalopathy
- •Gestational age at birth ≤32 weeks
- •Any known or suspected chromosomal abnormalities, abnormal development of vision or hearing, neurodevelopment retardation, or other known acquired or congenital abnormalities that might affect neurodevelopment
- •Significant cardiovascular surgery, significant ENT surgery, or neurosurgery
- •Malignant diseases that may reduce survival
- •Taking part in other clinical trials in the last 3 months or at present
研究组 & 干预措施
Long-time anesthesia exposure
Infants receive general anesthetics longer than 3 hours in total.
干预措施: General Anesthetics (Drug)
Short-time anesthesia exposure
Infants receive general anesthetics shorter than 3 hours in total.
干预措施: General Anesthetics (Drug)
结局指标
主要结局
Change of the developmental quotient of the Gesell Developmental Inventory
时间窗: From baseline before anesthesia to 1 year after anesthesia
The Gesell Developmental Inventory has been translated into Chinese and standardized by the Beijing Children's Health Care Institute and the performance results are expressed as a developmental quotient (DQ).
次要结局
- Change of the standardized score of the Social Maturity Scale(From baseline before anesthesia to 1 year after anesthesia)
- Change of the standardized score of the five domains of the Gesell Developmental Inventory(From baseline before anesthesia to 1 year after anesthesia)