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Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
NCT01090557 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Collection of exhaled breath
Study Locations (1)
New York
- Winthrop University Hospital — Mineola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01090557
The ClinicalTrials.gov registry entry for NCT01090557 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winthrop University Hospital, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bronchiolitis appearing as the primary indexed condition, and to 1 intervention — of which Collection of exhaled breath is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01090557 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01090557 about?
NCT01090557 is a clinical study titled "Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study". 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 exhal...
What is the current status of trial NCT01090557?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2007-10. Estimated completion is 2009-10.
What conditions does trial NCT01090557 study?
This clinical trial studies the following conditions: Bronchiolitis, RSV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01090557?
The interventions under investigation include: Collection of exhaled breath (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01090557?
This trial is sponsored by Winthrop University Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01090557 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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