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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05223192
Status
Recruiting
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Conditions

  • Prematurity

Eligibility Criteria

Sex
ALL
Age
24 Weeks - 37 Weeks
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 1, 2022
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention group
    Participants in this group will receive the ocean disc music therapy entrainment intervention
  • No Intervention: Control group
    Participants in this group will not receive any intervention

Primary Outcome Measure

Heart Rate [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalsNew YorkNew York10003
Joanne V Loewy, DA, LCAT, MT-BC
[email protected]
(212) 420-3484
Joanne V Loewy (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Hospitals· New York, NY

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