Effect of Use of a New Technique for Pediatric Urine Collection in ER (BLST)
Primary Purpose
Urinary Tract Infection, Unspecified Fever
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bladder and lumbar stimulation technic
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Children have unspecific fever and requiring and urine test
Exclusion Criteria:
- Initial shock state
- History of congenial urinary tract abnormality
- Parents who have declined taking part in the research
Sites / Locations
- Jeju national university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
bladder and lumbar stimulation
Control group
Arm Description
Apply bladder and lumbar stimulation
Ordinary pediatric urine collection bag
Outcomes
Primary Outcome Measures
Success rate of bladder and lumbar stimulation techninc
Success is defined as the collection of a sample within 10 min of starting the stimulation manoeuvres
Secondary Outcome Measures
Urine collection time
Urine collection time is defined as time from ordering urine analysis to collection of a urine sample
Full Information
NCT ID
NCT02117102
First Posted
April 14, 2014
Last Updated
April 15, 2014
Sponsor
Jeju National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02117102
Brief Title
Effect of Use of a New Technique for Pediatric Urine Collection in ER
Acronym
BLST
Official Title
Effect of Use of a New Technique for Pediatric Urine Collection on the Length of Stay in the Emergency Department: Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jeju National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.
In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.
The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.
Detailed Description
Bladder and lumbar stimulation technic
Step 1
- Oral or IV hydration : Aprropriate to the weight of the children
Step 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec
Step 3
- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec
Both stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Unspecified Fever
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bladder and lumbar stimulation
Arm Type
Experimental
Arm Description
Apply bladder and lumbar stimulation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Ordinary pediatric urine collection bag
Intervention Type
Other
Intervention Name(s)
Bladder and lumbar stimulation technic
Other Intervention Name(s)
BLST
Primary Outcome Measure Information:
Title
Success rate of bladder and lumbar stimulation techninc
Description
Success is defined as the collection of a sample within 10 min of starting the stimulation manoeuvres
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Urine collection time
Description
Urine collection time is defined as time from ordering urine analysis to collection of a urine sample
Time Frame
3 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children have unspecific fever and requiring and urine test
Exclusion Criteria:
Initial shock state
History of congenial urinary tract abnormality
Parents who have declined taking part in the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Ho Kang
Email
sivakjh1234@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung wook Song
Organizational Affiliation
Emergency department of Jeju national university hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jeju national university hospital
City
Jeju City
State/Province
Jeju special governing province
ZIP/Postal Code
690 767
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23172785
Citation
Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.
Results Reference
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Effect of Use of a New Technique for Pediatric Urine Collection in ER
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