Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT04293302
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2020-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Postnatal Management of Gestational Brain Sonographic Malformations.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2020-02-29', 'studyFirstSubmitQcDate': '2020-02-29', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any postnatal clinical neurologic or sonographic brain abnormality', 'timeFrame': '10 years', 'description': 'Post natal sonographic brain abnormality or clinical neurologic abnormality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Abnormalities']}, 'referencesModule': {'references': [{'pmid': '20020466', 'type': 'BACKGROUND', 'citation': 'Ghi T, Carletti A, Contro E, Cera E, Falco P, Tagliavini G, Michelacci L, Tani G, Youssef A, Bonasoni P, Rizzo N, Pelusi G, Pilu G. Prenatal diagnosis and outcome of partial agenesis and hypoplasia of the corpus callosum. Ultrasound Obstet Gynecol. 2010 Jan;35(1):35-41. doi: 10.1002/uog.7489.'}]}, 'descriptionModule': {'briefSummary': 'Gestational sonographic follow up may find some brain malformations. The trial is about to characterize these findings and correlate with the immediate postnatal findings.', 'detailedDescription': 'Gestational sonographic follow up may find some brain malformations (such as ventricular enlargement, agenesis of corpus callosum, etc.).The trial is about to characterize these findings and correlate with the immediate postnatal findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants who were born in Hillel Yaffe medical center during 2010-2019', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All term newborn infants who underwent a neurologic consultation or brain ultrasound.\n\nExclusion Criteria:\n\n* Prematurity'}, 'identificationModule': {'nctId': 'NCT04293302', 'briefTitle': 'Early Postnatal Management of Gestational Brain Sonographic Malformations.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Early Postnatal Management of Gestational Brain Sonographic Malformations.', 'orgStudyIdInfo': {'id': '0162-19-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brain abnormality', 'description': 'Newborn who had any gestational brain sonographic abnormality', 'interventionNames': ['Other: No intervention']}, {'label': 'No brain abnormality', 'description': 'Newborn who did not have any gestational brain sonographic abnormality', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Brain abnormality', 'No brain abnormality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Neonatal intensive care unit, Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Neonatologist', 'investigatorFullName': 'Erez Nadir, MD', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}