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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01862822
First received: May 22, 2013
Last updated: May 30, 2013
Last verified: December 2012
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The failure rate in upright position in private practice [ Time Frame: 1 hour. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1360
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   2 Months to 36 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01862822     History of Changes
Other Study ID Numbers: I11 016
Study First Received: May 22, 2013
Last Updated: May 30, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014