Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 10:51 AM
Study NCT ID:
NCT05223192
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2022-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '14 days'}, {'measure': 'Respiratory Rate', 'timeFrame': '14 days'}, {'measure': 'Oxygen-Saturation Level', 'timeFrame': '14 days'}, {'measure': 'Weight', 'timeFrame': '14 days'}, {'measure': 'Cerebral oxygen saturation', 'timeFrame': '14 days', 'description': 'Cerebral oxygen saturation measured using NIRS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'ocean disc', 'prematurity', 'vital signs', 'cerebral oxygenation'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': "Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '24 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newborns born at 24-37 weeks' gestation at Mount Sinai hospital\n* Newborn is considered appropriate for clinically indicated music therapy\n\nExclusion Criteria:\n\n* Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)\n* Infant of uncertain viability (gestation \\<23 weeks, birth weight \\<500 grams)\n* Known or suspected genetic disorder (e.g., Trisomy 21)\n* Identified hearing disorder"}, 'identificationModule': {'nctId': 'NCT05223192', 'briefTitle': 'The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants', 'orgStudyIdInfo': {'id': 'STUDY-21-01783'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in this group will receive the ocean disc music therapy entrainment intervention', 'interventionNames': ['Behavioral: Music Therapy Entrainment with Ocean Disc Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in this group will not receive any intervention'}], 'interventions': [{'name': 'Music Therapy Entrainment with Ocean Disc Intervention', 'type': 'BEHAVIORAL', 'description': "The studied intervention regards live entrainment with the ocean disc. Entrainment involves the use of an external stimulus, in the case of this study, an ocean disc instrument. Motion of the disc creates sounds in synchrony with the breathing of the infant and then in turn can control and influence the infant's regulation of the breath.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne V Loewy, DA, LCAT, MT-BC', 'role': 'CONTACT', 'email': 'joanne.loewy@mountsinai.org', 'phone': '(212) 420-3484'}, {'name': 'Joanne V Loewy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospitals', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Joanne V Loewy, DA, MT-BC, LCAT', 'role': 'CONTACT', 'email': 'joanne.loewy@mountsinai.org', 'phone': '(212) 420-3484'}, {'name': 'Elizabeth Barone', 'role': 'CONTACT', 'email': 'Elizabeth.Barone@mountsinai.org', 'phone': '212 420-2704'}], 'overallOfficials': [{'name': 'Joanne V Loewy, DA, MT-BC, LCAT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be made available upon reasonable request to corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Joanne Loewy', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}