Effects of music therapy on infants with Neonatal Abstinence Syndrome
The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
This study is testing if music therapy can help calm and support infants with Neonatal Abstinence Syndrome who were exposed to drugs before birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 28 Weeks and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 6 sites (New Orleans, Louisiana and 5 other locations) |
| Trial ID | NCT03533985 on ClinicalTrials.gov |
What this trial studies
This exploratory pilot study investigates the impact of six different music therapy interventions on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). The study involves administering six music therapy sessions over a 14-day period, utilizing a randomized treatment schedule. The aim is to determine if live music therapy can improve outcomes for neonates affected by NAS, a condition resulting from exposure to opiates in utero.
Who should consider this trial
Good fit: Ideal candidates for this study are infants admitted to the NICU immediately postpartum, with a gestational age of 28 weeks or older, and without any identified hearing disorders or developmental disabilities.
Not a fit: Patients who may not benefit from this study include those with gestational ages less than 28 weeks, diagnosed developmental disabilities, or those who are not medically cleared to participate.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive therapeutic option to improve the well-being of infants suffering from Neonatal Abstinence Syndrome.
How similar studies have performed: While music therapy has been explored in various contexts, this specific approach for treating Neonatal Abstinence Syndrome is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender: * Admitted to the NICU immediately postpartum * Gestational age 28 weeks or older * No identified hearing disorder * Do not have a diagnosed developmental disability (i.e. Down Syndrome) * Do not have Fetal Alcohol Syndrome * Medically cleared to participate in the study by nurse or neonatologist * Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire) Exclusion Criteria: * Admitted to the NICU at any time other than immediately postpartum * Gestational age \<28 weeks old * Has an identified hearing disorder * Has diagnosed developmental disability (i.e. Down syndrome) * Has Fetal Alcohol Syndrome * Is not medically cleared to participate in the study by the nurse or neonatologist * Parent or legal guardian unable/unwilling to give consent
Where this trial is running
New Orleans, Louisiana and 5 other locations
- Tulane University Hospital — New Orleans, Louisiana, United States (Recruiting)
- Joseph M. Sanzari Children's Hospital — Hackensack, New Jersey, United States (Recruiting)
- Northwell Health — New Hyde Park, New York, United States (Recruiting)
- Mount Sinai West — New York, New York, United States (Recruiting)
- Maria Fareri Children's Hospital — Valhalla, New York, United States (Recruiting)
- Drexel University/Hahnemann Hospital-College of Nursing and Health Professions — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Joanne Loewy, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Joanne Loewy, DA, LCAT, MT-BC
- 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.