Differentiating Outcome Measures in Infants/Young Children With Cystic Fibrosis Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Quantitative Air Trapping, A2 & A3
研究概览
简要总结
The objective of the study is to implement a new method of performing chest CT imaging in young children with cystic fibrosis at Packard Children's Hospital. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.
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
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and young children (age ~ 2/3 months to < 5 years)
- •Diagnosed with cystic fibrosis with either 2 identified CFTR gene mutations, or a positive sweat chloride
- •Informed consent by parent or legal guardian.
- •Ability to comply with study visit procedures as judged by the investigator.
排除标准
- •Acute wheezing and/or respiratory distress at either study visit.
- •Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.
- •Oxygen saturation < 90% on room air at study visit.
- •Any medical condition that in the opinion of the investigator precludes subject participation.
结局指标
主要结局
Quantitative Air Trapping, A2 & A3
时间窗: Baseline & F/U
Quantitative Chest CT Air Trapping by CT post-processing for Measure A2 \& Measure A3 (% of segmented total lung)
Quantitative CT Airway Measurements (AWT/TAD, LD/TAD, Wall Area %, Lumen Area %
时间窗: Baseline & F/U
Quantitative Chest CT airway measurements by CT Post-Processing. AWT/TAD = Airway Wall Thickness/Total Airway Diameter LD/TAD = Lumen Diameter/Total Airway Diameter Wall Area % = Wall Area/Total Airway Area (%)
次要结局
- FEF 85%(Baseline & F/U)
- FEF25-75%(Baseline & F/U)
- FEV 0.5 sec(Baseline & F/U)
研究者
Terry Robinson
Associate Professor
Stanford University