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NCT Number: NCT01090557

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of exhaled breath

Other

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

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness

    Time frame: 2 years

  2. FeNO levels in viral respiratory illness will vary with steroid use

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Winthrop University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 22, 2010
Registry last updated
Mar 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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