Exhaled Nitric Oxide Levels in Infants and Young Children Infected With RSV or Other Viral Infections
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|ClinicalTrials.gov Identifier: NCT01098227|
Recruitment Status : Withdrawn (The equipment to be used for the study was inoperable and not repairable.)
First Posted : April 2, 2010
Last Update Posted : December 28, 2015
The fraction of exhaled nitric oxide (FeNO) in expired air is a reliable measure of airway inflammation and has been used as a marker in asthma and other respiratory illnesses such as primary ciliary dyskinesia, bronchopulmonary dysplasia (BPD), liver cirrhosis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF). Although, some exquisite bench research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV, there is a paucity of clinical data regarding levels of feNO in viral respiratory illness and specifically RSV.
The investigators conducted a pilot study from the fall of 2007 until October of 2009, looking at FeNO levels in RSV infected patients and compared it to non-RSV viral infections. The investigators recruited a total of 28 RSV positive and 1 RSV negative subjects, as well as 4 control subjects. The investigators found FeNO values not statistically significant between the study group (the two-tailed p=0.09, considered not quite significant), but there was a trend of higher FeNO values in the non-RSV group when compared to the RSV group. A larger sample may detect a statistically significance between these 2 groups.
i. To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms.
ii. To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness.
Method of feNO measurement utilized 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.
The investigators plan that our sample sizes for the RSV+ and control groups will be, by design, three times as large as the RSV- group. In order to achieve 80% power, the investigators will then require 45 control and 45 RSV+ patients, and 15 RSV- patients
|Condition or disease|
|Bronchiolitis Infection Nitric Oxide|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Official Title:||A Prospective 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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
RSV positive subjects
Subjects admitted to Winthrop University Hospital with lower viral respiratory infection and RSV positive status by DFA and/or Viral culture
RSV negative subjects
Subjects admitted to Winthrop University Hospital with a lower viral respiratory infection and RSV status negative by DFA and viral culture. these subjects may be positive for other viruses detected by DFA or viral culture (Adenovirus, Influenza A or B, Metapneumovirus or parainfluenza) or not
Children in the same age range without respiratory conditions and who are well enough to perform the test from the out patient setting
- To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms [ Time Frame: 1 year ]
- To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness [ Time Frame: 1 year ]
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098227
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Maria L Quintos-Alagheband, MD||Winthrop University Hospital|