Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00753194
Status:
COMPLETED
Last Update Posted:
2008-09-16
First Post:
2008-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
False Positive Results in Newborn Hearing Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-15', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Otoacoustic Emissions', 'timeFrame': 'At birth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hearing', 'newborn', 'otoacoustic emissions'], 'conditions': ['Deafness']}, 'referencesModule': {'references': [{'pmid': '16504089', 'type': 'RESULT', 'citation': 'Grill E, Uus K, Hessel F, Davies L, Taylor RS, Wasem J, Bamford J. Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening. BMC Health Serv Res. 2006 Feb 23;6:14. doi: 10.1186/1472-6963-6-14.'}], 'seeAlsoLinks': [{'url': 'http://www.gatanu.org', 'label': 'Non profitable organization that implemented Newborn Hearing Screening in Brazil'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the rate of false-positive results in Newborn Universal Hearing Screening Programs and it´s possible causes.', 'detailedDescription': 'False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety and increase the cost of the procedure before hospital discharge. Getting to know the possible causes will lead to solutions to decrease the number of normal hearing babies that fail NHS with Otoacoustic Emissions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '6 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy newborns\n\nExclusion Criteria:\n\n* Risk factors for hearing loss'}, 'identificationModule': {'nctId': 'NCT00753194', 'acronym': 'NHS', 'briefTitle': 'False Positive Results in Newborn Hearing Screening', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'False-Positive Results in Newborn Hearing Screening: Possible Causes', 'orgStudyIdInfo': {'id': '2612'}, 'secondaryIdInfos': [{'id': '26129'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Newborns that show a "Pass" On the newborn hearing screening program before hospital discharge'}, {'label': '2', 'description': 'Newborns that show a "fail" and will be retested in 15 days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22.220-001', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Panamericano', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Marisa Frasson, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Maria Cristina Silva simonek', 'oldOrganization': 'Universidade Federal de Sao Paulo'}}}}