Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants With Elevated Sputum Eosinophils
研究概览
简要总结
We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 - 18 years of age at enrolment
- •Clinically stable at enrolment
- •Attending follow-up in the CDH Clinic at SickKids
排除标准
- •Unable to perform pulmonary function testing
- •Clinically unstable at enrolment
- •Known hypersensitivity to salbutamol
研究组 & 干预措施
Hypersaline and Bronchodilator Response
After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
干预措施: Hypersaline (Drug)
Hypersaline and Bronchodilator Response
After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
干预措施: Bronchodilator Response (Drug)
结局指标
主要结局
Number of Participants With Elevated Sputum Eosinophils
时间窗: post sputum induction
Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum
次要结局
- Number of Participant With Bronchodilator Response(life time of child (age 6 to present age))
- Number of Participant With Elevated Sputum Neutrophils(Baseline, +30 minutes)
- Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level(30 min)
研究者
Theo Moraes
Staff Respirologist
The Hospital for Sick Children