Clinical trial NCT03152851: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2017-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: The urine collection time
timeFrame: up to 2 hours
Secondary outcomes:
measure: The antibiotic administration time
timeFrame: up to 1 day
measure: Emergency department(ED) length of stay time
timeFrame: up to 1 day
measure: Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.
timeFrame: up to 1 day
measure: Complications
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: The Seoul National Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoum national university
Study officials:
affiliation: The Seoul National University Bundang Hospital
name: JAEYOON JUNG, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: