Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT03152851
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2017-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
Sponsor:
Seoul National University Bundang Hospital
Organization:
Study Overview
Official Title:
The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: