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Clinical Study of New Urine Collection Bag for Infants.

This study has been completed.
Sponsor:
Information provided by:
Bergaliden Barnavårdscentral
ClinicalTrials.gov Identifier:
NCT00368888
First received: August 28, 2006
Last updated: September 11, 2006
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention
Urinary Tract Infection
 Device: Urine collection bag for infants

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bergaliden Barnavårdscentral:

Study Start Date: March 2004
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children.

Exclusion Criteria:

  • Current infection of any kind. History of urinary tract infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368888

Locations
Sweden
Bergaliden Barnavårdscentral (Child Care Center)
Helsingborg, Sweden, 251 87
Sponsors and Collaborators
Bergaliden Barnavårdscentral
Investigators
Principal Investigator: Markus Perlhagen, Doctor
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00368888     History of Changes
Other Study ID Numbers: LIVI4099
Study First Received: August 28, 2006
Last Updated: September 11, 2006
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013