NCT00613184

Brief Summary

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. .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
Last Updated

February 12, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

January 29, 2008

Last Update Submit

February 11, 2008

Conditions

Keywords

Respiratory Syncytial virusBronchiolitisPediatric

Outcome Measures

Primary Outcomes (1)

  • Viral detection rate by PCR

    0 not applicable

Study Arms (4)

1

EXPERIMENTAL

Nylon Flocked swab Left Nasal Wash right

Device: Nylon Flocked swab (Nasal secretion sampling)

2

EXPERIMENTAL

Nylon Flocked swab R Nasal Wash L

Device: Nylon Flocked swab (Nasal secretion sampling)

3

EXPERIMENTAL

Nasal Wash Left Nylon Flocked swab Right

Device: Nylon Flocked swab (Nasal secretion sampling)

4

EXPERIMENTAL

Nasal Wash R Nylon flocked swab L

Device: Nylon Flocked swab (Nasal secretion sampling)

Interventions

Nasal Aspirate Nylon Flocked swab

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Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Treating clinican ordered RSV antigen testing

You may not qualify if:

  • Refusal of consent
  • Age \> 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, HumanBronchiolitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBronchitisBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Paul Walsh, MD

    Kern Medical Center & David Geffen School of Medicine UCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 12, 2008

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 12, 2008

Record last verified: 2008-01