Clinical trial Recruiting at 1 site Interventional Ages 24 Weeks to 37 Weeks

Effects of music therapy on breathing and brain oxygen levels in premature infants

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

Run by Icahn School of Medicine at Mount Sinai · NCT05223192 · Data updated 2026-11-12

This study tests if music therapy with ocean sounds can help improve breathing and oxygen levels in premature babies.

More Prematurity trials

Quick facts

Study typeInterventional
Ages24 Weeks to 37 Weeks
SexAll
Enrollment120 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedApril 1, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 13, 2026
Trial IDNCT05223192 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are newborns born at 24-37 weeks' gestation who are appropriate for clinically indicated music therapy.

Probably not a fit

Patients who are not expected to survive 24 hours, those with uncertain viability, known genetic disorders, or identified hearing disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of music therapy using ocean disc sounds on respiratory stability and cerebral oxygenation in preterm infants aged 24-37 weeks. Infants will be randomly assigned to either a treatment group receiving music therapy or a control group experiencing silence, with each infant undergoing both interventions in a randomized order. The study will take place over two weeks, with three sessions per week, and will monitor vital signs and oxygen levels before, during, and after each intervention. The goal is to assess whether music therapy can improve health outcomes for these vulnerable infants.

Why it matters

Potential benefit: If successful, this approach could enhance respiratory stability and oxygenation in preterm infants, potentially improving their overall health and development.

How similar studies have gone: While the specific use of ocean disc music therapy in this context may be novel, similar studies have shown positive effects of music therapy on preterm infants' health outcomes.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Mount Sinai Hospitals
    New York, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Joanne V Loewy, DA, MT-BC, LCAT — Icahn School of Medicine at Mount Sinai
  • Study coordinator: Joanne V Loewy, DA, MT-BC, LCAT
  • Email: joanne.loewy@mountsinai.org
  • Phone: (212) 420-3484

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.