Position of Children During Urine Collection: Evaluation Study

NCT01862822 | Completed

• 1 other identifier: I11 016
• Study Type: interventional
• Target: 803
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Infection

Keywords

Paediatrics; Urinary tract infection; Urine collection

Outcome Measures

Primary Outcomes (1)

• Proportion of polybacterial urine analysis in each group

  1 hour

Secondary Outcomes (1)

• The failure rate in upright position in private practice

  1 hour.

Study Arms (2)

upright position

EXPERIMENTAL

Upright position during urine bag collection

Other: upright position

usual position

NO INTERVENTION

Interventions

upright position OTHER

Also known as: the impact of an upright position on the number of contaminated urine cultures during urine bag collection

upright position

Eligibility Criteria

• Age: 2 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital, Limoges

Limoges, 87 042, France

Location

Related Publications (1)

• Bahans C, Dallocchio A, Tran A, Dubos F, Soto B, Schoder G, Blanc P, Messager V, Demonchy D, Labrunie A, Garnier F, Guigonis V. The position during urine sample collection from young precontinent children through a bag does not limit contamination rates: Results from a randomized controlled trial: Does infant position influence quality of urine collection? Arch Pediatr. 2022 Jul;29(5):359-363. doi: 10.1016/j.arcped.2022.03.007. Epub 2022 May 2.

  PMID: 35513967 RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 30, 2025

Record last verified: 2016-08

Locations

FR (1)