NCT01895465

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 4, 2013

Last Update Submit

July 22, 2013

Conditions

Keywords

urine collection, contamination

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

EXPERIMENTAL

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

Device: Slitted diaper

Interventions

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

Also known as: Huggies, Pampers, etc.
A slitted diaper

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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

Locations