Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of postoperative behavioral changes in the participants
研究概览
简要总结
Autism Spectrum Disorder (ASD) is the fastest growing neurodevelopmental disorder in the world. Approximately 1% of the population worldwide is affected by this disorder. Children with ASD exhibit some very stereo-typical behaviors. Their daily functionality depends on very rigid and predictable schedules and routines. Any changes in their schedules can often trigger negative emotional outbursts. The need to come to the hospital for procedures can be one such trigger. The purpose of this study is to examine the post anesthesia behavior outcomes of children with ASD.
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 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 2 years through 17 years of age scheduled for a procedure with anesthesia at Boston Children's Hospital
- •Patients must have a diagnosis of Autism Spectrum Disorder (ASD) according to the DSM IV and DSM V (autism group) or an ASA score of I or II and no history of neurodevelopmental concerns (control group)
排除标准
- •Families who are not able to read and speak English well enough to complete the validated surveys
结局指标
主要结局
Incidence of postoperative behavioral changes in the participants
时间窗: up to two weeks following anesthesia
次要结局
未报告次要终点
研究者
Bistra Vlassakova
MD
Boston Children's Hospital
