Improvement in Urine Collection Methods in Children

NCT ID: NCT01895465

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Urinary Tract Infection; Unspecified Fever

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

A slitted diaper

An ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper

Group Type: EXPERIMENTAL

Slitted diaper

Intervention Type: DEVICE

A diaper where a slit is made through which a urine collection bag is pulled through

Interventions

Slitted diaper

A diaper where a slit is made through which a urine collection bag is pulled through

Intervention Type: DEVICE

Other Intervention Names

Huggies, Pampers, etc.

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

waisman yehezkel

Associate Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Countries

Israel

Facility Contacts

Yehezkel Waisman, Prof.

Role: primary

waisy@clalit.org.il

972-3-9253661

Other Identifiers

SCHNEIDER/7329

Identifier Type: -

Identifier Source: org_study_id