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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01895465
Recruitment Status : Unknown
Verified July 2013 by waisman yehezkel, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2013
Last Update Posted : July 23, 2013
Information provided by (Responsible Party):
waisman yehezkel, 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Unspecified Fever Device: Slitted diaper Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Improvement in Urine Collection Methods in Children
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Huggies, Pampers, etc.

Primary Outcome Measures :
  1. Recording of time elapsed between physician's request for an urine test to be taken until obtained [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percentage of contamination in urine cultures obtained [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01895465

Schneider Children's Medical Center of Israel Not yet recruiting
Petach Tikva, Israel, 49202
Contact: Yehezkel Waisman, Prof.    972-3-9253661   
Principal Investigator: Yehezkel Waisman, Prof.         
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: waisman yehezkel, Associate Professor, MD, Rabin Medical Center Identifier: NCT01895465     History of Changes
Other Study ID Numbers: SCHNEIDER/7329
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013

Keywords provided by waisman yehezkel, Rabin Medical Center:
urine collection, contamination

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases