Effects of music therapy on breathing and brain oxygen levels in premature infants
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
This study tests if music therapy with ocean sounds can help improve breathing and oxygen levels in premature babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 24 Weeks to 37 Weeks |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05223192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns born at 24-37 weeks' gestation who are appropriate for clinically indicated music therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.