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NCT00368888 Clinical Trial

Clinical Study of New Urine Collection Bag for Infants.

Urinary Tract Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00368888
Other study ID # LIVI4099
Secondary ID
Status Completed
Phase N/A
First received August 28, 2006
Last updated September 11, 2006
Start date March 2004
Est. completion date September 2006

Study information
Verified date September 2006
Source Bergaliden Barnavårdscentral
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

To determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Years
Eligibility Inclusion Criteria:

- Healthy children.

Exclusion Criteria:

- Current infection of any kind. History of urinary tract infection.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Urine collection bag for infants

Locations
Country Name City State
Sweden Bergaliden Barnavårdscentral (Child Care Center) Helsingborg

Sponsors (1)
Lead Sponsor Collaborator
Bergaliden Barnavårdscentral

Country where clinical trial is conducted

Sweden, 

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