Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 7:26 PM
Study NCT ID:
NCT05188235
Status:
TERMINATED
Last Update Posted:
2024-11-04
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sound Conduction of Infant Hips
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}], 'ancestors': [{'id': 'D006617', 'term': 'Hip Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'Study terminated upon departure of PI from Sponsoring Institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in soundwaves on the Actuator on patella, sensor on sacrum', 'timeFrame': 'Study visit 1 (Day 1)', 'description': 'Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings'}, {'measure': 'Difference in soundwaves on the Actuator on patella, sensor on anterior superior iliac crest of pelvis', 'timeFrame': 'Study visit 1 (Day 1)', 'description': 'Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings'}, {'measure': 'Difference in soundwaves on the Actuator on greater trochanter, sensor on sacrum', 'timeFrame': 'Study visit 1 (Day 1)', 'description': 'Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings'}, {'measure': 'Difference in soundwaves on the Actuator on greater trochanter, sensor on anterior superior iliac crest', 'timeFrame': 'Study visit 1 (Day 1)', 'description': 'Descriptive statistics will be used to evaluate sound wave characteristics in infants with healthy hips. Inferential statistics will be used to compare the relationship between soundwave characteristics and diagnostic findings'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Developmental Dysplasia of the Hip']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).', 'detailedDescription': 'This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH.\n\nFor both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants included in this study must be born at full term with a gestational age of 0-6 months\n* Infants of both genders will be included\n* Infants must have been screened for DDH.\n\nExclusion Criteria:\n\n* Infants born prematurely\n* Infants greater than six months of age.\n* Nonviable neonates and neonates of uncertain viability'}, 'identificationModule': {'nctId': 'NCT05188235', 'briefTitle': 'Sound Conduction of Infant Hips', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Pilot Study on the Evaluation of Sound Conduction of Healthy Infant Hips and Those With Developmental Dysplasia of the Hip (DDH)', 'orgStudyIdInfo': {'id': '21-01096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infants with developmental dysplasia of the hip', 'description': 'Infant participants putting on a device for 15 minutes to take different measurements of the hip', 'interventionNames': ['Device: Acoustical Resonance Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infants without developmental dysplasia of the hip', 'description': 'Infant participants putting on a device for 15 minutes to take different measurements of the hip', 'interventionNames': ['Device: Acoustical Resonance Device']}], 'interventions': [{'name': 'Acoustical Resonance Device', 'type': 'DEVICE', 'description': 'Infants will be studied for 15 min using an electronic "tuning fork" to transmit sound through the hip from a point on the skin while transmitted sounds FDA-approved stethoscope', 'armGroupLabels': ['Infants with developmental dysplasia of the hip', 'Infants without developmental dysplasia of the hip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pablo Castaneda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Lagone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to study team members. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Central Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}