The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Primary Purpose
Prematurity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy Entrainment with Ocean Disc Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity focused on measuring music therapy, ocean disc, prematurity, vital signs, cerebral oxygenation
Eligibility Criteria
Inclusion Criteria:
- Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
- Newborn is considered appropriate for clinically indicated music therapy
Exclusion Criteria:
- 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)
- Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)
- Known or suspected genetic disorder (e.g., Trisomy 21)
- Identified hearing disorder
Sites / Locations
- Mount Sinai HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants in this group will receive the ocean disc music therapy entrainment intervention
Participants in this group will not receive any intervention
Outcomes
Primary Outcome Measures
Heart Rate
Respiratory Rate
Oxygen-Saturation Level
Weight
Cerebral oxygen saturation
Cerebral oxygen saturation measured using NIRS
Secondary Outcome Measures
Full Information
NCT ID
NCT05223192
First Posted
January 24, 2022
Last Updated
March 19, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05223192
Brief Title
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Official Title
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
music therapy, ocean disc, prematurity, vital signs, cerebral oxygenation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in this group will receive the ocean disc music therapy entrainment intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will not receive any intervention
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy Entrainment with Ocean Disc Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Heart Rate
Time Frame
14 days
Title
Respiratory Rate
Time Frame
14 days
Title
Oxygen-Saturation Level
Time Frame
14 days
Title
Weight
Time Frame
14 days
Title
Cerebral oxygen saturation
Description
Cerebral oxygen saturation measured using NIRS
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
Newborn is considered appropriate for clinically indicated music therapy
Exclusion Criteria:
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)
Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)
Known or suspected genetic disorder (e.g., Trisomy 21)
Identified hearing disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne V Loewy, DA, MT-BC, LCAT
Phone
(212) 420-3484
Email
joanne.loewy@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Barone
Phone
212 420-2704
Email
Elizabeth.Barone@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy, DA, MT-BC, LCAT
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospitals
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy, DA, LCAT, MT-BC
Phone
(212) 420-3484
Email
joanne.loewy@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be made available upon reasonable request to corresponding author
Learn more about this trial
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
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