Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 9:14 AM
Study NCT ID:
NCT00872703
Status:
COMPLETED
Last Update Posted:
2009-03-31
First Post:
2009-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-30', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neuropsychological outcome', 'timeFrame': '1-7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CMV', 'Prenatal Diagnosis', 'Ultrasound', 'MRI'], 'conditions': ['CMV', 'Prenatal Diagnosis', 'Ultrasound', 'MRI']}, 'descriptionModule': {'briefSummary': "Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most likely to occur when the mother experiences a primary infection during pregnancy, and it is much less common in cases of reactivation of the disease or infection by a different CMV strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between 0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).\n\nIt is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a major risk factor for perceptual deficits. However, its influence on children's future neuropsychological functioning is less well established. Symptomatic congenital CMV infection is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard 2007), but the available data regarding neuropsychological outcome for asymptomatic children is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).\n\nWe evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV) infection and normal consecutive fetal neurosonographic examinations and determined whether Magnetic Resonance Imaging (MRI) provided additional information in these cases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children of woman with CMV proved intrauterine infections', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CMV PCR positive in the amniotic fluid\n\nExclusion Criteria:\n\n* US abnormal findings during fetal life'}, 'identificationModule': {'nctId': 'NCT00872703', 'briefTitle': 'Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?', 'orgStudyIdInfo': {'id': 'SR-907'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}, {'label': '2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '58000', 'city': 'Holon', 'country': 'Israel', 'facility': 'E. Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Tel Aviv Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gustavo Malinger, MD, Director OB-GYN Ultrasound Unit'}}}}