Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study - Full Text View

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:

MedlinePlus related topics: Respiratory Syncytial Virus Infections

Drug Information available for: Nitric oxide

U.S. FDA Resources

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

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:

American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. No abstract available.

Baraldi E, de Jongste JC; European Respiratory Society; American Thoracic Society. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37.

Gentile DA, Doyle WJ, Belenky S, Ranck H, Angelini B, Skoner DP. Nasal and oral nitric oxide levels during experimental respiratory syncytial virus infection of adults. Acta Otolaryngol. 2002 Jan;122(1):61-6.

Ricciardolo FL, Sterk PJ, Gaston B, Folkerts G. Nitric oxide in health and disease of the respiratory system. Physiol Rev. 2004 Jul;84(3):731-65. Review.

Kao YJ, Piedra PA, Larsen GL, Colasurdo GN. Induction and regulation of nitric oxide synthase in airway epithelial cells by respiratory syncytial virus. Am J Respir Crit Care Med. 2001 Feb;163(2):532-9.

Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8.

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
Respiratory Syncytial Virus Infections
Respiratory Tract Infections
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Infection
Nitric Oxide

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013