Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00847951
Status:
WITHDRAWN
Last Update Posted:
2017-09-19
First Post:
2009-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound for Perfusion in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study terminated at this time by investigator. Will create new protocol.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if ultrasound imaging can accurately help physicians determine if the kidneys are being adequately perfused.', 'timeFrame': '1 year', 'description': 'Fractional blood volume was determined as a way to measure kidney perfusion. Adequate perfusion indicates that the kidneys are working and might indicate if a baby was responding to a specific treatment or not.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal', 'neonates'], 'conditions': ['Kidney Perfusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of renal ultrasound to check kidney perfusion in premature and/or very low birth weight babies.', 'detailedDescription': 'The purpose of this study is to evaluate the effectiveness of 3D (3 dimensional)renal ultrasound to check kidney perfusion (to see if the kidney is receiving enough blood flow to function as it should) in premature and/or very low birth weight babies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very low birth weight babies in ICU in stable condition and/or premature babies in ICU in stable condition\n\nExclusion Criteria:\n\n* Unstable very low birth weight/premature babies'}, 'identificationModule': {'nctId': 'NCT00847951', 'briefTitle': 'Ultrasound for Perfusion in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': '3D Ultrasound for Perfusion in Neonates', 'orgStudyIdInfo': {'id': 'HUM00021322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Renal perfusion in Neonates', 'description': 'Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys.', 'interventionNames': ['Procedure: 3D Ultrasound Imaging']}], 'interventions': [{'name': '3D Ultrasound Imaging', 'type': 'PROCEDURE', 'description': 'Ultrasound scanning with power Doppler is used to determine the fractional blood volume of the kidneys in pre-mature and/or very low birth weight babies. This is a measure of perfusion and an indication of how well the kidneys are working.', 'armGroupLabels': ['Renal perfusion in Neonates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jonathan Rubin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Michigan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jonathan Rubin, M.D.', 'investigatorAffiliation': 'University of Michigan'}}}}