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

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. Read our disclaimer for details. Identifier: NCT01862822
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : May 27, 2013
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Infection Other: upright position Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Position of Children During Urine Collection: Evaluation Study
Study Start Date : May 2013
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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

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

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 identifier (NCT number): NCT01862822

Contact: Vincent GUIGONIS, MD

University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Vincent GUIGONIS, MD   
Sponsors and Collaborators
University Hospital, Limoges

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

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

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases