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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
waisman yehezkel, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01895465
First received: July 4, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Urinary Tract Infection
Unspecified Fever
Device: Slitted diaper

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Improvement in Urine Collection Methods in Children

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Recording of time elapsed between physician's request for an urine test to be taken until obtained [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of contamination in urine cultures obtained [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Huggies, Pampers, etc.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895465

Locations
Israel
Schneider Children's Medical Center of Israel Not yet recruiting
Petach Tikva, Israel, 49202
Contact: Yehezkel Waisman, Prof.    972-3-9253661    waisy@clalit.org.il   
Principal Investigator: Yehezkel Waisman, Prof.         
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: waisman yehezkel, Associate Professor, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01895465     History of Changes
Other Study ID Numbers: SCHNEIDER/7329
Study First Received: July 4, 2013
Last Updated: July 22, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
urine collection, contamination

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014