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

NCT05223192 | Recruiting

• 1 other identifier: STUDY-21-01783
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

music therapy; ocean disc; prematurity; vital signs; cerebral oxygenation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this group will receive the ocean disc music therapy entrainment intervention

Behavioral: Music Therapy Entrainment with Ocean Disc Intervention

Control group

NO INTERVENTION

Participants in this group will not receive any intervention

Interventions

Music Therapy Entrainment with Ocean Disc Intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 24 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
• Newborn is considered appropriate for clinically indicated music therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospitals

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Joanne V Loewy, DA, MT-BC, LCAT

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne V Loewy, DA, MT-BC, LCAT

CONTACT

(212) 420-3484; joanne.loewy@mountsinai.org

Elizabeth Barone

CONTACT

212 420-2704; Elizabeth.Barone@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)