Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-30 @ 3:20 PM
Study NCT ID:
NCT01780103
Status:
UNKNOWN
Last Update Posted:
2013-01-30
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of hydronephrosis by sonographic measures', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pyelectasis of Newborns']}, 'descriptionModule': {'briefSummary': 'In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test.\n\nThese babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month.\n\nThe investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'newborns at the age of 0-1 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01780103', 'briefTitle': 'Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis', 'orgStudyIdInfo': {'id': 'HYMC-0055-12-CTIL'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist MD', 'investigatorFullName': 'Dr Sylvia Foldi', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}