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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
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Infection focused on measuring Paediatrics, Urinary tract infection, Urine collection

Eligibility Criteria

2 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
May 22, 2013
Last Updated
January 11, 2019
Sponsor
University Hospital, Limoges
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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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