Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-08 @ 1:34 AM
Study NCT ID:
NCT02086760
Status:
WITHDRAWN
Last Update Posted:
2015-10-02
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006869', 'term': 'Hydronephrosis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no subject enrolled within one year following EC and IRB approvals.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care", 'timeFrame': 'V2 (Age of 6 months)', 'description': "The primary outcome measure is a composite outcome measure consisting of multiple measures.\n\nIndeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydratation and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size.\n\nThe measures will be done before, 30 min and 90 min following oral hydration.\n\nFor scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed.\n\nThe result will be reported as a single value, ie:\n\n* the treating surgeon's decision and the independent surgeon's decision are similar (=1) or\n* the treating surgeon's decision and the independent surgeon's decision are not similar (=0)"}], 'secondaryOutcomes': [{'measure': "Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care", 'timeFrame': 'Between V0 (age: 30 days ) and V2 (age: 6 months)', 'description': "The secondary outcome measure is a composite outcome measure consisting of multiple measures.\n\nIndeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydration and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography with oral hydration, he will make a decision aposteriori.\n\nFor ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size.\n\nThe measures will be done before, 30 min and 90 min following oral hydration.\n\nFor scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed.\n\nThe result will be reported as a single value, ie:\n\n* the treating surgeon's decision and the independent surgeon's decision are similar (=1) or\n* the treating surgeon's decision and the independent surgeon's decision are not similar (=0)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hydronephrosis'], 'conditions': ['Hydronephrosis in Children']}, 'descriptionModule': {'briefSummary': 'Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child of 30 days old or less\n* unilateral or bilateral hydronephrosis (pelvis \\> 5mm )\n\nExclusion Criteria:\n\n* complex uropathy\n* diuretic administration 6 hours prior to ultrasonography or scintigraphy\n* oral feeding trouble'}, 'identificationModule': {'nctId': 'NCT02086760', 'briefTitle': 'Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?', 'orgStudyIdInfo': {'id': '5580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasonography sensibilized by oral hydratation', 'description': 'Ultrasonography before, 30 min and 90 min following hydratation.', 'interventionNames': ['Other: Ultrasonography with oral hydration', 'Radiation: Scintigraphy']}], 'interventions': [{'name': 'Ultrasonography with oral hydration', 'type': 'OTHER', 'description': 'Before, 30 min and 90 min following oral hydration', 'armGroupLabels': ['Ultrasonography sensibilized by oral hydratation']}, {'name': 'Scintigraphy', 'type': 'RADIATION', 'armGroupLabels': ['Ultrasonography sensibilized by oral hydratation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Isabelle LACREUSE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}