Back to resultsClinical Study of New Urine Collection Bag for Infants.
Primary Purpose
Urinary Tract Infection
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Urine collection bag for infants
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria: Healthy children. Exclusion Criteria: Current infection of any kind. History of urinary tract infection.
Sites / Locations
- Bergaliden Barnavårdscentral (Child Care Center)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00368888
First Posted
August 28, 2006
Last Updated
September 11, 2006
Sponsor
Bergaliden Barnavårdscentral
1. Study Identification
Unique Protocol Identification Number
NCT00368888
Brief Title
Clinical Study of New Urine Collection Bag for Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bergaliden Barnavårdscentral
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Urine collection bag for infants
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children.
Exclusion Criteria:
Current infection of any kind. History of urinary tract infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Perlhagen, Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bergaliden Barnavårdscentral (Child Care Center)
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of New Urine Collection Bag for Infants.
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