Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 6:12 AM
Study NCT ID:
NCT02919358
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music and Feeding in NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is time to regain birth weight', 'timeFrame': '2 weeks', 'description': 'We will track weight gain and will monitor how long it takes for the babies to regain their birth weight.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Feeding Cues', 'timeFrame': '2 weeks', 'description': 'At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Feeding', 'NICU', 'Preterm Infants', 'Mozart', 'Weight Gain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '31 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days\n\n * Parents ≥18 years of age\n * English speaking parents\n * Breastmilk as intended primary form of nutrition\n\nExclusion Criteria:\n\n* Congenital anomalies affecting hearing or feeding skills\n* Patients requiring HFOV or HFJV'}, 'identificationModule': {'nctId': 'NCT02919358', 'briefTitle': 'Music and Feeding in NICU', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.', 'orgStudyIdInfo': {'id': 'DDD603441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'Exposure to music, twice per day for the study period', 'interventionNames': ['Other: Music']}, {'type': 'OTHER', 'label': 'Control', 'description': 'No intervention; standard care.', 'interventionNames': ['Other: No music.']}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'armGroupLabels': ['Music']}, {'name': 'No music.', 'type': 'OTHER', 'description': 'This is the control group.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}