NCT01158495已完成不适用
Differentiating Outcome Measures in Infant and Early Childhood Lung Disease Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantitative CT air trapping & airway measurements
研究概览
简要总结
To implement a new method of performing chest CT imaging in young children at Packard Children's Hospital entitled controlled ventilation infant/young child chest CT scanning. 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
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 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 <= 3 months to < 5 years) and either 2) or 3) below.
- •Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia, bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a pediatric pulmonologist at LPCH.
- •Oncology condition (e.g. young children with or without cancer, who are being screened for lung metastasis) and are being followed by pediatric oncologists at LPCH.
- •For minors, 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 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 CT air trapping & airway measurements
时间窗: 6 mo
次要结局
- Functional residual capacity (FRC) & Lung Clearance Index (LCI).(6 mo)
- Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI.(6 mo)
- Correlation between LCI and quantitative air trapping(6 mo)
- Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC(6 mo)
研究者
研究点 (1)
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