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Position of Children During Urine Collection: Evaluation Study (PUCES)

This study is currently recruiting participants.
Verified June 2016 by University Hospital, Limoges
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862822
First Posted: May 27, 2013
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  Purpose
Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.

Condition Intervention
Urinary Infection Other: upright position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Position of Children During Urine Collection: Evaluation Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Proportion of polybacterial urine analysis in each group [ Time Frame: 1 hour ]

Secondary Outcome Measures:
  • The failure rate in upright position in private practice [ Time Frame: 1 hour. ]

Estimated Enrollment: 1360
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: upright position
Upright position during urine bag collection
Other: upright position
Other Name: the impact of an upright position on the number of contaminated urine cultures during urine bag collection
No Intervention: usual position

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 2 - 36 months
  • Non-toilet-trained children
  • Indication to bag urine collection with the following criteria :
  • fever ≥ 38.5 °C
  • unexplained fever
  • and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
  • age ≤ 12 months
  • fever ≥ 48 hours
  • poorly tolerated fever (chills ± cyanosis ± pronounced weakness…)
  • preceding episode of tract urine infection

Exclusion Criteria:

  • Parents opposed to the participation of their children in the study
  • Diarrhea
  • Current antibiotic treatment or during the 8 preceding days of the urine collection
  • Genitals / perineal anomaly
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862822


Contacts
Contact: Vincent GUIGONIS, MD v.guigonis@gmail.com

Locations
France
University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Vincent GUIGONIS, MD       v.guigonis@gmail.com   
Sponsors and Collaborators
University Hospital, Limoges
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01862822     History of Changes
Other Study ID Numbers: I11 016
First Submitted: May 22, 2013
First Posted: May 27, 2013
Last Update Posted: August 22, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Limoges:
Paediatrics
Urinary tract infection
Urine collection

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases