Surgery in Early Life and Child Development at School-entry: A Population-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188,628
- 试验地点
- 1
- 主要终点
- Early developmental vulnerability
研究概览
简要总结
The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.
The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.
The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the Early Development Instrument in Ontario
排除标准
- •Children with physical or developmental disabilities identified in the Early Development Instrument
- •Not born in Canada
- •Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
- •Patients of a cardiology or cardiovascular service
结局指标
主要结局
Early developmental vulnerability
时间窗: Assessed between five and six years of age
Any major domain of the Early Development Instrument in the lowest 10th percentile
次要结局
- Performance in specific Early Development Instrument domains(Assessed between five and six years of age)
- Multiple challenge index(Assessed between five and six years of age)
研究者
James O'Leary
Staff Anesthesiologist
The Hospital for Sick Children