Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-02 @ 5:33 AM
Study NCT ID:
NCT03152851
Status:
UNKNOWN
Last Update Posted:
2018-04-18
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The urine collection time', 'timeFrame': 'up to 2 hours', 'description': 'The urine collection time'}], 'secondaryOutcomes': [{'measure': 'The antibiotic administration time', 'timeFrame': 'up to 1 day', 'description': 'The antibiotic administration time'}, {'measure': 'Emergency department(ED) length of stay time', 'timeFrame': 'up to 1 day', 'description': 'Emergency department(ED) length of stay time'}, {'measure': 'Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.', 'timeFrame': 'up to 1 day', 'description': 'Comparison between the patients who were diagnosed as actual urinary tract'}, {'measure': 'Complications', 'timeFrame': 'up to 1 month', 'description': 'Complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "* According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow.\n* Get documented agreement from the caregiver if the patient meets the criteria.\n* 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)\n* If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient.\n* 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.\n* If the AP X T was less than 2 X 2, excluded from the study enrollment.\n* During the study, caregivers and the assigned nurse will be blinded"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body temperature of patients ≥ 38℃ reported by guardians\n* No definite focus of fever detected by physical examination\n* Guardian agrees to use urine bag(kismo) collection technique\n\nExclusion Criteria:\n\n* Previous history of urinary tract infections\n* Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)\n* ICU treatment indicated\n* Newly diagnosed hydronephrosis on the day of visit'}, 'identificationModule': {'nctId': 'NCT03152851', 'briefTitle': 'The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'B-1609-362-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pressure stimulus group by ultrasound probe', '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', 'interventionNames': ['Procedure: Pressure stimulus group']}, {'type': 'NO_INTERVENTION', 'label': 'Non-pressure stimulus group', 'description': 'No pressure stimulus would be given'}], 'interventions': [{'name': 'Pressure stimulus group', 'type': 'PROCEDURE', 'armGroupLabels': ['Pressure stimulus group by ultrasound probe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'YOOJIN CHOI, MD', 'role': 'CONTACT', 'email': 'choiyj0729@naver.com', 'phone': '82-10-9360-9468'}], 'facility': 'The Seoul National Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jaeyoon Jung, Dr', 'role': 'CONTACT', 'email': 'matewoos@gmail.com'}], 'facility': 'Seoum national university', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'YOOJIN CHOI, MD', 'role': 'CONTACT', 'email': 'choiyj0729@naver.com', 'phone': '82-10-9360-9468'}], 'overallOfficials': [{'name': 'JAEYOON JUNG, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant Professor', 'investigatorFullName': 'Hyuksool Kwon', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}