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| Sponsors and Collaborators: |
Kern Medical Center Medical Diagnostic Laboratories Copan Innovation Murrietta, CA |
| Information provided by: | Kern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00613184 |
Purpose
Collection of nasal secretions from infants and toddlers for viral testing is usually done using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly designed swab may work better and in this study we compare the new swab with the old style nasal washing.
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| Condition | Intervention |
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Respiratory Syncytial Virus Human Metapneumovirus Influenza Bronchiolitis Pediatric |
Device: Nylon Flocked swab (Nasal secretion sampling) |
| MedlinePlus related topics: | Flu |
| ChemIDplus related topics: | Sodium chloride Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Crossover Assignment, Efficacy Study |
| Official Title: | Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses |
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Nylon Flocked swab Left Nasal Wash right
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Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Device: Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash
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2: Experimental
Nylon Flocked swab R Nasal Wash L
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Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
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3: Experimental
Nasal Wash Left Nylon Flocked swab Right
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Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
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4: Experimental
Nasal Wash R Nylon flocked swab L
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Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
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Collection of nasal secretions from infants and toddlers for viral testing is typically performed using the nasal saline aspirate technique described by Hall in 1975.
Nylon flocked swabs (NFS) and universal transport medium for room temperature (UTM-RT) (Copan Medical, Murrieta, CA) storage media have been found to be an effective collection and transport method for bacteria causing sexually transmitted infections.
We adapted these swabs and storage medium to collect respiratory viruses from children less than18 months old and compared detection rates using NFS and traditional nasal aspirates. We will determine the relative roles of the UTM-RT and NFS release and therefore measured viral detection rates of common respiratory pathogens in traditional saline aspirates stored in UTM-RT.
Our primary hypothesis is that nasal secretions collection using NFS stored in UTM-RT will lead to a higher detection rate of the respiratory viruses we arestudying; namely RSV, Influenza and human metapneumovirus from than collection of unpreserved saline nasal aspirates in children less than 18 months of age.
Eligibility
| Ages Eligible for Study: | up to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
Departmental web page
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| Responsible Party: | Department of Emergency Medicine, Kern Medical Center ( Paul Walsh MB BCh FACEP ) |
| Study ID Numbers: | kmc06037 |
| First Received: | January 29, 2008 |
| Last Updated: | February 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00613184 |
| Health Authority: | United States: Institutional Review Board |
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