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

Completed

• Conditions: RSV Infection; Bronchiolitis
• Interventions: Other: Collection of exhaled breath

• Registration Number: NCT01090557
• Lead Sponsor: Winthrop University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-06
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-19
• Last Update Submitted: 2010-03-19
• Study First Posted: 2010-03-22
• Last Update Posted: 2010-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RSV positive subjects	Collection of exhaled breath	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
RSV negative subjects	Collection of exhaled breath	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)
Control group	Collection of exhaled breath	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States