跳至主要内容
临床试验/NCT02707939
NCT02707939Unknown不适用

Observational Prospective Study on Behavioral Outcomes of Children With Autism Spectrum Disorder (ASD) in Comparison to Those Without Neurodevelopmental Diagnoses

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bistra Vlassakova

MD

Boston Children's Hospital

研究点 (1)

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