Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
NCT ID: NCT01090557
Last Updated: 2010-03-22
Study Results
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Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2007-10-31
2009-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
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)
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
Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
Interventions
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Collection of exhaled breath
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Day
4 Years
ALL
Yes
Sponsors
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Winthrop University Hospital
OTHER
Responsible Party
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Division of Pediatric Critical Care,Winthrop University Hospital
Principal Investigators
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Maria L Quintos-Alagheband, MD
Role: PRINCIPAL_INVESTIGATOR
Winthrop University Hospital
Locations
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Winthrop University Hospital
Mineola, New York, United States
Countries
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References
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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. doi: 10.1164/rccm.200406-710ST. No abstract available.
Baraldi E, de Jongste JC; European Respiratory Society/American Thoracic Society (ERS/ATS) Task Force. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37. doi: 10.1183/09031936.02.00293102.
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. doi: 10.1080/00016480252775751.
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. doi: 10.1152/physrev.00034.2003.
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. doi: 10.1164/ajrccm.163.2.9912068.
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. doi: 10.1164/ajrccm.159.4.9807084.
Other Identifiers
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07029
Identifier Type: -
Identifier Source: org_study_id
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