Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-31 @ 9:28 AM
Study NCT ID:
NCT04988061
Status:
WITHDRAWN
Last Update Posted:
2022-09-29
First Post:
2021-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with loss to follow-ups in all participants whose infants require follow-ups', 'timeFrame': '6 months', 'description': 'A loss to follow-up rate which is calculated from number of participants with loss to follow-ups divided by number of all participants whose infants require follow-ups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Newborn Morbidity']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The parents whose infants do not pass hearing screening\n\nExclusion Criteria:\n\n* The parents whose infants have illnesses and are not ready for hearing screening\n* The parents who decide to migrate to other areas'}, 'identificationModule': {'nctId': 'NCT04988061', 'briefTitle': 'Proactive Counselling Towards Follow-ups in Newborn Hearing Screening', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening', 'orgStudyIdInfo': {'id': '64-220-13-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Counselling arm', 'description': 'Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.', 'interventionNames': ['Other: counselling']}, {'type': 'NO_INTERVENTION', 'label': 'standard arm', 'description': 'The information about hearing screening results and an appointment date are provided as a routine by either nurses or nurse assistances who perform the screening test.'}], 'interventions': [{'name': 'counselling', 'type': 'OTHER', 'description': 'Educating and Counselling with personal communication for 10-15 minutes and written information about the importance of early identification and intervention for hearing loss are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.', 'armGroupLabels': ['Counselling arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Pittayapon Pitathawatchai', 'investigatorAffiliation': 'Prince of Songkla University'}}}}