Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT02117102
Status:
UNKNOWN
Last Update Posted:
2014-04-17
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Use of a New Technique for Pediatric Urine Collection in ER
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': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-15', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of bladder and lumbar stimulation techninc', 'timeFrame': '10 min', 'description': 'Success is defined as the collection of a sample within 10 min of starting the stimulation manoeuvres'}], 'secondaryOutcomes': [{'measure': 'Urine collection time', 'timeFrame': '3 hour', 'description': 'Urine collection time is defined as time from ordering urine analysis to collection of a urine sample'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urinary Tract Infection', 'Unspecified Fever']}, 'referencesModule': {'references': [{'pmid': '23172785', 'type': 'BACKGROUND', 'citation': 'Herreros Fernandez ML, Gonzalez Merino N, Tagarro Garcia A, Perez Seoane B, de la Serna Martinez M, Contreras Abad MT, Garcia-Pose A. A new technique for fast and safe collection of urine in newborns. Arch Dis Child. 2013 Jan;98(1):27-9. doi: 10.1136/archdischild-2012-301872. Epub 2012 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.\n\nIn 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.\n\nThe aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.', 'detailedDescription': 'Bladder and lumbar stimulation technic\n\nStep 1\n\n\\- Oral or IV hydration : Aprropriate to the weight of the children\n\nStep 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec\n\nStep 3\n\n\\- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec\n\nBoth stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children have unspecific fever and requiring and urine test\n\nExclusion Criteria:\n\n* Initial shock state\n* History of congenial urinary tract abnormality\n* Parents who have declined taking part in the research'}, 'identificationModule': {'nctId': 'NCT02117102', 'acronym': 'BLST', 'briefTitle': 'Effect of Use of a New Technique for Pediatric Urine Collection in ER', 'organization': {'class': 'OTHER', 'fullName': 'Jeju National University Hospital'}, 'officialTitle': 'Effect of Use of a New Technique for Pediatric Urine Collection on the Length of Stay in the Emergency Department: Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BLSTJEJUNUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bladder and lumbar stimulation', 'description': 'Apply bladder and lumbar stimulation', 'interventionNames': ['Other: Bladder and lumbar stimulation technic']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Ordinary pediatric urine collection bag'}], 'interventions': [{'name': 'Bladder and lumbar stimulation technic', 'type': 'OTHER', 'otherNames': ['BLST'], 'armGroupLabels': ['bladder and lumbar stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '690 767', 'city': 'Jeju City', 'state': 'Jeju Special Governing Province', 'country': 'South Korea', 'facility': 'Jeju national university hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}], 'centralContacts': [{'name': 'Jeong Ho Kang', 'role': 'CONTACT', 'email': 'sivakjh1234@gmail.com'}], 'overallOfficials': [{'name': 'Sung wook Song', 'role': 'STUDY_CHAIR', 'affiliation': 'Emergency department of Jeju national university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeju National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency department', 'investigatorFullName': 'Kang Jeong Ho', 'investigatorAffiliation': 'Jeju National University Hospital'}}}}