Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 3:48 AM
Study NCT ID:
NCT01113450
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-29', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-04-29', 'lastUpdatePostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hearing, newborn, screening'], 'conditions': ['Showing the Results of a Program of NHS in Cuiaba_ Brazil']}, 'descriptionModule': {'briefSummary': 'The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).', 'detailedDescription': "The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '2 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There were two groups:\n\n1. high risk for hearing loss\n2. low risk for hearing loss', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* middle ear conditions integrates\n\nExclusion Criteria:\n\n* middle ear conditions inadequate'}, 'identificationModule': {'nctId': 'NCT01113450', 'briefTitle': 'Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Diagnostico Auditivo de Cuiaba'}, 'officialTitle': 'Results of a Program of Newborn Hearing Screening in Cuiaba-Brazil', 'orgStudyIdInfo': {'id': 'TAN Cuiaba'}}, 'contactsLocationsModule': {'locations': [{'zip': '78000000', 'city': 'Cuiabá', 'state': 'Mato Grosso', 'country': 'Brazil', 'facility': 'CEDAC', 'geoPoint': {'lat': -15.59611, 'lon': -56.09667}}], 'overallOfficials': [{'name': 'Priscila L Rodrigues, PHD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Diagnostico Auditivo de Cuiaba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Diagnostico Auditivo de Cuiaba', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Priscila de Araujo Lucas Rodrigues', 'oldOrganization': 'CEDAC'}}}}