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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 24 Weeks to 37 Weeks |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | April 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT05223192 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.
-
Household, wellbeing, and quality-of-life impacts of very preterm birth and necrotising enterocolitis
This project will collect information to see if pausing or continuing milk feeds around blood transfusions relates to babies' quality of life and the financial and emotional impact on families of very preterm infants, especially those with NEC.
-
Giving surfactant to premature infants using a thin catheter at birth
This study is testing if giving a special lung treatment to very premature babies right after birth using a thin tube can help them breathe better and need less breathing support in their first few days of life.
-
Earlier use of an electric breast pump to maximize milk in preterm babies
This study tests whether starting a double electric breast pump earlier (at birth) helps mothers of very preterm infants produce more milk by day 14.
-
Adding azithromycin to ampicillin for late PPROM
This test sees if adding a single dose of azithromycin to the usual ampicillin/amoxicillin treatment helps newborns when membranes break early between 34.0 and 36.6 weeks.
-
Medically tailored groceries to support pregnant people facing food insecurity
This project will test whether home-delivered medically tailored groceries, with or without extra food education, help Medicaid-eligible pregnant people in Cuyahoga County improve nutrition and birth outcomes.
-
Tracking intellectual and motor development in babies at high risk for cerebral palsy
This project will follow babies at higher risk for cerebral palsy to see if early thinking and movement signs predict later intellectual and motor outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.