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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
  Purpose

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.


Condition Intervention
RSV Infection
Bronchiolitis
Other: Collection of exhaled breath

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
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)
Other: Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
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
Other: Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090557

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Maria L Quintos-Alagheband, MD Winthrop University Hospital
  More Information

Publications:
Responsible Party: Maria Lyn Quintos-Alagheband, MD, Division of Pediatric Critical Care,Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01090557     History of Changes
Other Study ID Numbers: 07029
Study First Received: October 6, 2009
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Communicable Diseases
Infection
Respiratory Syncytial Virus Infections
Respiratory Tract Infections
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Mononegavirales Infections
Paramyxoviridae Infections
Pneumovirus Infections
RNA Virus Infections
Respiratory Tract Diseases
Virus Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 24, 2014