Position of Children During Urine Collection: Evaluation Study (PUCES)
Primary Purpose
Urinary Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
upright position
Sponsored by
About this trial
This is an interventional other trial for Urinary Infection focused on measuring Paediatrics, Urinary tract infection, Urine collection
Eligibility 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
Sites / Locations
- University Hospital, Limoges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
upright position
usual position
Arm Description
Upright position during urine bag collection
Outcomes
Primary Outcome Measures
Proportion of polybacterial urine analysis in each group
Secondary Outcome Measures
The failure rate in upright position in private practice
Full Information
NCT ID
NCT01862822
First Posted
May 22, 2013
Last Updated
January 11, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT01862822
Brief Title
Position of Children During Urine Collection: Evaluation Study
Acronym
PUCES
Official Title
Position of Children During Urine Collection: Evaluation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Infection
Keywords
Paediatrics, Urinary tract infection, Urine collection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
803 (Actual)
8. Arms, Groups, and Interventions
Arm Title
upright position
Arm Type
Experimental
Arm Description
Upright position during urine bag collection
Arm Title
usual position
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
upright position
Other Intervention Name(s)
the impact of an upright position on the number of contaminated urine cultures during urine bag collection
Primary Outcome Measure Information:
Title
Proportion of polybacterial urine analysis in each group
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
The failure rate in upright position in private practice
Time Frame
1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87 042
Country
France
12. IPD Sharing Statement
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Position of Children During Urine Collection: Evaluation Study
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