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

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ClinicalTrials.gov Identifier: NCT03152851
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Hyuksool Kwon, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Procedure: Pressure stimulus group Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pressure stimulus group by ultrasound probe
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
Procedure: Pressure stimulus group
No Intervention: Non-pressure stimulus group
No pressure stimulus would be given



Primary Outcome Measures :
  1. The urine collection time [ Time Frame: up to 2 hours ]
    The urine collection time


Secondary Outcome Measures :
  1. The antibiotic administration time [ Time Frame: up to 1 day ]
    The antibiotic administration time

  2. Emergency department(ED) length of stay time [ Time Frame: up to 1 day ]
    Emergency department(ED) length of stay time

  3. Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not. [ Time Frame: up to 1 day ]
    Comparison between the patients who were diagnosed as actual urinary tract

  4. Complications [ Time Frame: up to 1 month ]
    Complications



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Ages Eligible for Study:   3 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152851


Contacts
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Contact: YOOJIN CHOI, MD 82-10-9360-9468 choiyj0729@naver.com

Locations
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Korea, Republic of
The Seoul National Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Contact: YOOJIN CHOI, MD    82-10-9360-9468    choiyj0729@naver.com   
Seoum national university Recruiting
Seoul, Korea, Republic of
Contact: Jaeyoon Jung, Dr       matewoos@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Seoul National University Hospital
Investigators
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Principal Investigator: JAEYOON JUNG, MD PhD The Seoul National University Bundang Hospital

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Responsible Party: Hyuksool Kwon, Clinical assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03152851     History of Changes
Other Study ID Numbers: B-1609-362-001
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases