Improvement in Urine Collection Methods in Children

Urinary Tract Infection Clinical Trial

— 0244-12-RMC  

Official title:

Improvement in Urine Collection Methods in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01895465
• Other study ID #: SCHNEIDER/7329
• Status: Not yet recruiting
• Phase: N/A
• First received: July 4, 2013
• Last updated: July 22, 2013
• Start date: August 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 14 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Unspecified Fever
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• Slitted diaper
A diaper where a slit is made through which a urine collection bag is pulled through

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of time elapsed between physician's request for an urine test to be taken until obtained		12 months	No
Secondary	Percentage of contamination in urine cultures obtained		12 months	No