Improvement in Urine Collection Methods in Children
0244-12-RMC
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 23, 2013
July 1, 2013
1 year
July 4, 2013
July 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recording of time elapsed between physician's request for an urine test to be taken until obtained
12 months
Secondary Outcomes (1)
Percentage of contamination in urine cultures obtained
12 months
Study Arms (1)
A slitted diaper
EXPERIMENTALAn ordinary pediatric urine collection bag used in the ED that will be used together with the slitted diaper
Interventions
A diaper where a slit is made through which a urine collection bag is pulled through
Eligibility Criteria
You may qualify if:
- Children incapable of giving urine voluntarily in the Emergency Department
- Children requiring an urine test
- Children whose parents have agreed to take part in the research and have signed a consent form
You may not qualify if:
- Children who have an immediate medical condition which requires catheterization
- Parents who have declined taking part in the research
- Children who give urine voluntarily
- Children who do not need an urine test for their continued treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, 49202, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, MD
Study Record Dates
First Submitted
July 4, 2013
First Posted
July 10, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2014
Study Completion
July 1, 2015
Last Updated
July 23, 2013
Record last verified: 2013-07