Position of Children During Urine Collection: Evaluation Study

Urinary Infection Clinical Trial

— PUCES  

Official title:

Position of Children During Urine Collection: Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862822
• Other study ID #: I11 016
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Urinary Infection
• Urinary Tract Infections

Intervention

Other:
• upright position

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of polybacterial urine analysis in each group		1 hour
Secondary	The failure rate in upright position in private practice		1 hour.