Exhaled Nitric Oxide Levels in Infants and Young Children Infected With RSV or Other Viral Infections
Public ClinicalTrials.gov record NCT01098227. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Objectives: 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
Study identification
- NCT ID
- NCT01098227
- Recruitment status
- Withdrawn
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Up to 4 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- May 31, 2011
- Completion
- May 31, 2011
- Last update posted
- Mar 15, 2020
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01098227, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01098227 live on ClinicalTrials.gov.