Position of Children During Urine Collection: Evaluation Study

NCT ID: NCT01862822

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

upright position

Upright position during urine bag collection

Group Type: EXPERIMENTAL

upright position

Intervention Type: OTHER

usual position

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

upright position

Intervention Type: OTHER

Other Intervention Names

the impact of an upright position on the number of contaminated urine cultures during urine bag 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Limoges

Limoges, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 35513967 (View on PubMed)

Other Identifiers

I11 016

Identifier Type: -

Identifier Source: org_study_id