Prospective Cohort Study of Effects of Exposure to General Anaesthesia in Infancy on Neurocognitive Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Neurocognitive Assessment: Bayley's Scale of Infant Development-III
研究概览
简要总结
This prospective cohort study aims to determine if apparently healthy children with no significant co-morbidities who undergo general anaesthesia for minor surgery before 15 months of age will develop measurable deficits in neurocognitive development compared to apparently healthy children with no significant co-morbidities who do not undergo general anaesthesia or surgery.
详细描述
We hypothesize that healthy children exposed to general anaesthesia for minor surgery before 15 months of age will have significantly lower neurocognitive scores at 6,18, 24 and 36 months of age compared with age, and gender matched healthy children from the GUSTO cohort without prior exposure to general anaesthesia or surgery. (GUSTO: Growing Up Towards Healthy Outcomes in Singapore: a prospective longitudinal study providing normative data from the local population).
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
- 1 Day 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born > 36 weeks gestation
- •No significant co-morbidities
- •Who undergo general sevoflurane anaesthesia for minor surgery lasting <150 minutes (including herniotomies, orchidopexies, circumcisions and pyloromyotomies) before 15 months of age
排除标准
- •Prematurity <36 weeks gestation
- •Birth weight less than 2400g
- •Presence of a genetic or chromosomal disorder
- •Disorder of the central nervous system, including any seizure disorder
- •Major congenital cardiac defects
结局指标
主要结局
Neurocognitive Assessment: Bayley's Scale of Infant Development-III
时间窗: 24 months of age
Bayley's Scale of Infant Development-III
次要结局
- Neurocognitive Assessment: Habituation(6 and 18 months of age)
- Visual Expectation(6 and 18 months of age)
- Event Related Potential(6 and 18 months of age)
- Neurocognitive Assessment: Deferred Imitation(6 and 18 months of age)
- Behavioural Assessment: Child behaviour checklist(24 months of age)