Improvement in Urine Collection Methods in Children (0244-12-RMC)

July 22, 2013 updated by: waisman yehezkel, Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
        • Contact:
        • Principal Investigator:
          • Yehezkel Waisman, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A slitted diaper
An ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper
Device: Slitted diaper
A diaper where a slit is made through which a urine collection bag is pulled through
Other Names:
  • Huggies, Pampers, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recording of time elapsed between physician's request for an urine test to be taken until obtained
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of contamination in urine cultures obtained
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHNEIDER/7329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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