Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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RSV Infection, Bronchiolitis

Intervention / Treatment
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* Other: Collection of exhaled breath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection Exclusion Criteria: asthma/RAD recurrent wheezing recurrent bronchiolitis allergic rhinitis atopy 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 HIV sickle cell anemia cardiac pulmonary bypass liver cirrhosis alpha-1 anti-trypsin disease interstitial lung

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RSV positive subjects<br>Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are positive for RSV by Direct Fluorescent Antibody technique and/or viral culture | Other: Collection of exhaled breath<br>* balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement<br>|
| RSV negative subjects<br>Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are negative for RSV by Direct Fluorescent Antibody technique and/or viral culture (usually positive for influenza A & B, parainfluenza, human metapneumovirus or adenovirus) | Other: Collection of exhaled breath<br>* balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement<br>|
| Control group<br>Children with same age range, ethnic background, and gender distribution as the study group coming for evaluation in the outpatient setting without evidence of viral infection | Other: Collection of exhaled breath<br>* balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |