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

This study has been completed.
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01090557
First received: October 6, 2009
Last updated: March 19, 2010
Last verified: March 2010

October 6, 2009
March 19, 2010
October 2007
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090557 on ClinicalTrials.gov Archive Site
  • FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • FeNO levels in viral respiratory illness will vary with steroid use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The parents of children admitted to WUH with a diagnosis of lower respiratory tract viral illness (LRTVI) will be offered the opportunity to participate

  • RSV Infection
  • Bronchiolitis
Other: Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
  • RSV positive subjects
    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
    Intervention: Other: Collection of exhaled breath
  • RSV negative subjects
    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)
    Intervention: Other: Collection of exhaled breath
  • Control group
    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
    Intervention: Other: Collection of exhaled breath

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
up to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01090557
07029
Yes
Maria Lyn Quintos-Alagheband, MD, Division of Pediatric Critical Care,Winthrop University Hospital
Winthrop University Hospital
Not Provided
Principal Investigator: Maria L Quintos-Alagheband, MD Winthrop University Hospital
Winthrop University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP