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

Urinary Tract Infections Clinical Trial

Official title:

The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152851
• Other study ID #: B-1609-362-001
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2017
• Last updated: April 16, 2018
• Start date: November 1, 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2018
• Source: Seoul National University Bundang Hospital
• Contact: YOOJIN CHOI, MD
• Phone: 82-10-9360-9468
• Email: choiyj0729[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Procedure:
• Pressure stimulus group

Locations

Country	Name	City	State
Korea, Republic of	The Seoul National Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoum national university	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The urine collection time	The urine collection time	up to 2 hours
Secondary	The antibiotic administration time	The antibiotic administration time	up to 1 day
Secondary	Emergency department(ED) length of stay time	Emergency department(ED) length of stay time	up to 1 day
Secondary	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	up to 1 day
Secondary	Complications	Complications	up to 1 month