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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01090557
Enrollment
60
Registered
2010-03-22
Start date
2007-10-31
Completion date
2009-10-31
Last updated
2010-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis, RSV Infection

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.

Interventions

balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement

Sponsors

Winthrop University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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 subjects2 years

Secondary

MeasureTime frame
FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness2 years
FeNO levels in viral respiratory illness will vary with steroid use2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026