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The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics

Primary Purpose

Urinary Tract Infections

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pressure stimulus group
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections

Eligibility Criteria

3 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Seoul National Bundang HospitalRecruiting
  • Seoum national universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pressure stimulus group by ultrasound probe

Non-pressure stimulus group

Arm Description

A 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

No pressure stimulus would be given

Outcomes

Primary Outcome Measures

The urine collection time
The urine collection time

Secondary Outcome Measures

The antibiotic administration time
The antibiotic administration time
Emergency department(ED) length of stay time
Emergency department(ED) length of stay time
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
Comparison between the patients who were diagnosed as actual urinary tract
Complications
Complications

Full Information

First Posted
May 10, 2017
Last Updated
April 16, 2018
Sponsor
Seoul National University Bundang Hospital
Collaborators
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03152851
Brief Title
The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
Official Title
The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow. Get documented agreement from the caregiver if the patient meets the criteria. While the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (AP) and transverse (T) diameter(cm) If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient. If the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior & posterior wall meet. If the AP X T was less than 2 X 2, excluded from the study enrollment. During the study, caregivers and the assigned nurse will be blinded

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure stimulus group by ultrasound probe
Arm Type
Experimental
Arm Description
A 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
Arm Title
Non-pressure stimulus group
Arm Type
No Intervention
Arm Description
No pressure stimulus would be given
Intervention Type
Procedure
Intervention Name(s)
Pressure stimulus group
Primary Outcome Measure Information:
Title
The urine collection time
Description
The urine collection time
Time Frame
up to 2 hours
Secondary Outcome Measure Information:
Title
The antibiotic administration time
Description
The antibiotic administration time
Time Frame
up to 1 day
Title
Emergency department(ED) length of stay time
Description
Emergency department(ED) length of stay time
Time Frame
up to 1 day
Title
Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
Description
Comparison between the patients who were diagnosed as actual urinary tract
Time Frame
up to 1 day
Title
Complications
Description
Complications
Time Frame
up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YOOJIN CHOI, MD
Phone
82-10-9360-9468
Email
choiyj0729@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAEYOON JUNG, MD PhD
Organizational Affiliation
The Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Seoul National Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YOOJIN CHOI, MD
Phone
82-10-9360-9468
Email
choiyj0729@naver.com
Facility Name
Seoum national university
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeyoon Jung, Dr
Email
matewoos@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics

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