Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-03-03 @ 4:30 AM
Study NCT ID:
NCT03072368
Status:
UNKNOWN
Last Update Posted:
2017-03-07
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015903', 'term': 'Moire Topography'}], 'ancestors': [{'id': 'D010780', 'term': 'Photogrammetry'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007368', 'term': 'Interferometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in eye color', 'timeFrame': 'One year', 'description': 'Change will be measured according to a validated classification of blue/hazel/green or brown'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye Color']}, 'descriptionModule': {'briefSummary': 'The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '2 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.\n\nExclusion Criteria:\n\n* Neonatal conjunctivitis\n* Neonatal sepsis\n* Inborn error of metabolism or genetic syndrome\n* Eye abnormalities\n* Parental refusal'}, 'identificationModule': {'nctId': 'NCT03072368', 'briefTitle': 'Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics', 'orgStudyIdInfo': {'id': 'HYMC-0081-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Blue eyes', 'description': '50 babies born with blue eyes will be photographed and followed-up at baseline; 3 months and 12 months of age', 'interventionNames': ['Other: Photograph']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brown eyes', 'description': '50 babies born with brown eyes will be photographed and followed-up at baseline; 3 months and 12 months of age', 'interventionNames': ['Other: Photograph']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Green eyes', 'description': '50 babies born with green eyes will be photographed and followed-up at baseline; 3 months and 12 months of age', 'interventionNames': ['Other: Photograph']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hazel eyes', 'description': '50 babies born with hazel eyes will be photographed and followed-up at baseline; 3 months and 12 months of age', 'interventionNames': ['Other: Photograph']}], 'interventions': [{'name': 'Photograph', 'type': 'OTHER', 'description': 'Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age', 'armGroupLabels': ['Blue eyes', 'Brown eyes', 'Green eyes', 'Hazel eyes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Amit Hochberg, MD', 'role': 'CONTACT', 'email': 'amith@hy.health.gov.il'}], 'overallOfficials': [{'name': 'Amit Hochberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}