Improvement in Urine Collection Methods in Children

Not Applicable

• Conditions: Urinary Tract Infection; Unspecified Fever
• Interventions: Device: Slitted diaper

• Registration Number: NCT01895465
• Lead Sponsor: Rabin Medical Center

Brief Summary

The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones.

Urinary tract infections in children are a common cause of death due to acute and chronic complications alike. Our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.

Detailed Description

The study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. The innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Children incapable of giving urine voluntarily in the Emergency Department
2. Children requiring an urine test
3. Children whose parents have agreed to take part in the research and have signed a consent form

Exclusion Criteria

1. Children who have an immediate medical condition which requires catheterization
2. Parents who have declined taking part in the research
3. Children who give urine voluntarily
4. Children who do not need an urine test for their continued treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A slitted diaper	Slitted diaper	An ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper

Primary Outcome Measures

Name	Time	Method
Recording of time elapsed between physician's request for an urine test to be taken until obtained	12 months

Secondary Outcome Measures

Name	Time	Method
Percentage of contamination in urine cultures obtained	12 months

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel