Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Lung Function
研究概览
简要总结
The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
详细描述
We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 Infants between 2 and 24 months that are healthy
- •Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing
排除标准
- •Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity < 37 weeks, and cannot be in the ICU.
研究组 & 干预措施
Infants with viral lower respiratory infections
Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants
干预措施: Inhaled primatene will be given as a breathing treatment (Drug)
Infants with viral lower respiratory infections
Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants
干预措施: Nasal Washing (Other)
Healthy Control
Healthy infants between the ages of 2-24 month
干预措施: Inhaled primatene will be given as a breathing treatment (Drug)
Healthy Control
Healthy infants between the ages of 2-24 month
干预措施: Nasal Washing (Other)
Bronchiolitis-Nasal wash only
Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only
干预措施: Nasal Washing (Other)
结局指标
主要结局
Lung Function
时间窗: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)
Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.
Endothelial Growth Factor (VEGF)
时间窗: During nasal wash
Analysis for VEGF level by ELISA
次要结局
未报告次要终点