NCT03002792Unknown不适用
Neurodevelopment Outcomes After Pediatric Dental Caries Treatment Under General Anaesthesia
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 360 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
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Full Scale Intelligence Quotient (IQ)
研究概览
简要总结
The purpose of this study is to investigate whether early expose to general anaesthesia will influence neurodevelopment.
详细描述
Participants, according to the state of illness and clinical requirements, assigned to receive dental caries treatment with or without general anesthesia. During the follow-up, various of neurodevelopment assessment will be done at specific timepoint to investigate whether general anaesthesia will influence neurodevelopment.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age>=36 weeks
- •American Society of Anesthesiologists（ASA） physical status Ⅰ or Ⅱ，with very limited systemic disease.
- •Age<=6 yr
排除标准
- •did not provide research authorization；
- •unable to contact or inconvenient for follow-up;
- •hypersensitive to general anesthesia drug;
- •previous exposure to general anesthesia in utero;
- •previous exposure to general anesthesia as a neonate
- •previous exposure to psychotropic medication;
- •complications at birth such as low weigh, hypoxia, or cerebral edema;
- •any other known diseases may influence the neurodevelopment
结局指标
主要结局
Full Scale Intelligence Quotient (IQ)
时间窗: 24-28 weeks after enrollment
according to Wechsler Preschool and Primary Scale of Intelligence fourth edition (WPPSI-IV)
次要结局
- Working Memory Index(24-28 weeks after enrollment)
- Adaptive Behavior(24-28 weeks after enrollment)
- Fluid Spatial Index(24-28 weeks after enrollment)
- Processing Speed Index(24-28 weeks after enrollment)
- Emotion Comprehension(24-28 weeks after enrollment)
- Verbal Comprehension Index(24-28 weeks after enrollment)
- Visual Spatial Index(24-28 weeks after enrollment)
- Executive Function(24-28 weeks after enrollment)
研究者
Hui Zhang
M.D., Ph.D. Director and Professor, Department of Anaesthesiology, School of Stomatology
Air Force Military Medical University, China
研究点 (1)
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