NCT04398862招募中不适用
Measures of Pulmonary Health in Children With Down Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Airway reactance
研究概览
简要总结
The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 18 years, inclusive, at time of consent
- •Diagnosis of Down syndrome/trisomy 21 or mosaicism
- •Able to walk
- •Had a swallow study (video fluoroscopic swallow study or fiberoptic endoscopic evaluation of swallowing) performed within 5 years of consent date
排除标准
- •Pregnant or lactating
- •Nonambulatory
- •Have a tracheostomy or other known severe glottic or subglottic obstruction that would significantly affect the results of testing
- •Have a significant acute respiratory illness, defined as treatment with steroids, antibiotics, or an increase in supplemental oxygen
- •have a medical illness that would a)increase the risk the participate would incur by participating in the study, b) interfere with the outcomes of the study, or c) interfere with the performance of study participants
- •Have a severe behavioral problem that would interfere with the performance of study procedures
结局指标
主要结局
Airway reactance
时间窗: Baseline
Airway reactance (X5) measured using forced oscillation technique at 5 Hertz
Total airway resistance
时间窗: Baseline
Airway resistance (R5) measured using forced oscillation technique at 5 Hertz
次要结局
- Change in airway reactance after albuterol(Baseline)
- Health-related quality of life, as measured by the Pediatric Quality of Life Inventory(Baseline)
- Change in total airway resistance after albuterol(Baseline)
研究者
研究点 (1)
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