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NCT01090557 · ClinicalTrials.gov registry record
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
A clinical trial of Bronchiolitis and RSV Infection, sponsored by Winthrop University Hospital.
- Completed
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT01090557 is a study of Bronchiolitis and RSV Infection that has completed, run by Winthrop University Hospital. The registered enrollment target is 60 participants, below the 572-participant average among 12 other Bronchiolitis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01090557, a study of Bronchiolitis and RSV Infection, has completed, sponsored by Winthrop University Hospital.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
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, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 572-participant average among 12 other Bronchiolitis trials with a reported enrollment target (90% lower). The listed sponsor is Winthrop University Hospital, which has 32 total studies on file at ClinicalTrials.gov.
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.
NCT01090557 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
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.
What interventions are being tested in trial NCT01090557?
The interventions under investigation include: Collection of exhaled breath (OTHER).
Who is sponsoring clinical trial NCT01090557?
This trial is sponsored by Winthrop University Hospital, which has 32 total clinical trials registered on ClinicalTrials.gov.
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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Related
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