The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
1 other identifier
interventional
80
1 country
2
Brief Summary
Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER stay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
2 active sites
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
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedApril 18, 2018
April 1, 2018
2.2 years
May 10, 2017
April 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The urine collection time
The urine collection time
up to 2 hours
Secondary Outcomes (4)
The antibiotic administration time
up to 1 day
Emergency department(ED) length of stay time
up to 1 day
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
up to 1 day
Complications
up to 1 month
Study Arms (2)
Pressure stimulus group by ultrasound probe
EXPERIMENTALA pressure stimulus would be applied once using a device (ultrasound probe) to the anteroposterior wall of the bladder until the anterior \& posterior wall meet if the measured diameters (AP x T) is 2 X 2 or more by ultrasound
Non-pressure stimulus group
NO INTERVENTIONNo pressure stimulus would be given
Interventions
Eligibility Criteria
You may qualify if:
- Body temperature of patients ≥ 38℃ reported by guardians
- No definite focus of fever detected by physical examination
- Guardian agrees to use urine bag(kismo) collection technique
You may not qualify if:
- Previous history of urinary tract infections
- Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)
- ICU treatment indicated
- Newly diagnosed hydronephrosis on the day of visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Seoul National Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoum national university
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JAEYOON JUNG, MD PhD
The Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant Professor
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 15, 2017
Study Start
November 1, 2016
Primary Completion
December 31, 2018
Study Completion
March 31, 2019
Last Updated
April 18, 2018
Record last verified: 2018-04