A Prospective, Pilot Study Measuring Exhaled Nitric Oxide Levels in Infants and Young Children Admitted to the Hospital for Respiratory Syncytial Virus (RSV) or Other Viral Lower Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects
研究概览
简要总结
The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV.
The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness and to determine if there is a difference in feNO level between RSV and non-RSV infection.
NO may play a role in the association between RSV, airway reactivity, and airway inflammation.
This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years of age admitted to Winthrop University Hospital, as well as controls (children in the same age range without respiratory conditions and who are well enough to perform the test). Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) & DFA) and via direct fluorescent antigen technique (DFA) for influenza A & B, parainfluenza, human metapneumovirus and adenovirus.
Method of feNO measurement will utilize the offline options for preschool children & infants appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society & the European Respiratory Society when discussing tidal breathing techniques with uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.
The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection
排除标准
- •asthma/RAD
- •recurrent wheezing
- •"recurrent bronchiolitis"
- •allergic rhinitis
- •chronic lung disease
- •hypertension
- •heart failure
- •pulmonary hypertension
- •primary ciliary dyskinesia
- •bronchiectasis
- •alveolitis
- •lung transplant rejection
- •pulmonary sarcoidosis
- •chronic cough (i.e. greater four weeks)
- •systemic sclerosis
- •hypersensitivity
- •cystic fibrosis
- •sickle cell anemia
- •cardiac pulmonary bypass
- •liver cirrhosis
- •alpha-1 anti-trypsin disease
- •interstitial lung
结局指标
主要结局
Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects
时间窗: 2 years
次要结局
- FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness(2 years)
- FeNO levels in viral respiratory illness will vary with steroid use(2 years)