The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Prematurity
• Intervention / Treatment: Behavioral: Music Therapy Entrainment with Ocean Disc Intervention

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Barone; Phone Number: 212 420-2704; Email: Elizabeth.Barone@mountsinai.org
• Study Contact Backup: Name: Joanne V Loewy, DA, MT-BC, LCAT; Phone Number: (212) 420-3484; Email: joanne.loewy@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • Mount Sinai Hospitals
      • Contact: Joanne V Loewy, DA, LCAT, MT-BC; Phone Number: (212) 420-3484; Email: joanne.loewy@mountsinai.org
      • Principal Investigator: Joanne V Loewy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in this group will receive the ocean disc music therapy entrainment intervention	Behavioral: Music Therapy Entrainment with Ocean Disc Intervention; 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.
No Intervention: Control group; Participants in this group will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate		14 days
Respiratory Rate		14 days
Oxygen-Saturation Level		14 days
Weight		14 days
Cerebral oxygen saturation	Cerebral oxygen saturation measured using NIRS	14 days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Joanne V Loewy, DA, MT-BC, LCAT, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: music therapy; prematurity; cerebral oxygenation; vital signs; ocean disc
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: STUDY-21-01783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be made available upon reasonable request to corresponding author

Drug and device information, study documents

• 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