Music Therapy for Neonatal Abstinence Syndrome

Recruiting at 6 trial locations

Overseen By Elizabeth Barone, MA, MT-BC, CCLS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Hearing disorder, Developmental disability, Fetal Alcohol Syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

How does the music therapy treatment for neonatal abstinence syndrome differ from other treatments?

Music therapy for neonatal abstinence syndrome is unique because it uses specific musical elements like contingent singing and instruments such as the Gato box and ocean disc to soothe infants, which is different from standard non-drug methods like swaddling or rocking. This approach focuses on reducing withdrawal symptoms through auditory stimulation, potentially enhancing parental bonding and reducing the need for medication. ^{1 2 3 4 5}

Who Is on the Research Team?

Kathy Murphy, PhD

Principal Investigator

Loyola University

Aimee Telsey, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Joanne Loewy, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for infants with Neonatal Abstinence Syndrome who are at least 28 weeks gestational age, without hearing disorders or developmental disabilities like Down Syndrome. They must be admitted to the NICU right after birth and have a guardian able to consent and complete a questionnaire.

Inclusion Criteria

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)

Gestational age 28 weeks or older

Exclusion Criteria

Admitted to the NICU at any time other than immediately postpartum

Gestational age <28 weeks old

I have a diagnosed hearing disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 6 music therapy sessions over a 14-day period with different interventions

2 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingent singing
• Gato box
• Muted shaker
• Ocean disc
• Song of Kin
• Tonal Vocal holding

Trial Overview The study tests six music therapy interventions: Ocean disc, Contingent singing, Muted shaker, Song of Kin, Gato box, Tonal Vocal holding on newborns with Neonatal Abstinence Syndrome to see how they affect the babies' outcomes.

How Is the Trial Designed?

Group I: Tonal Vocal holding Experimental Treatment 1 Intervention

Providing a 'blanket of tone' to comfort, engage or sedate

Group II: Song of Kin Experimental Treatment 1 Intervention

Voice (with or without guitar)- lullaby/ Holding meter

Group III: Ocean disc Experimental Treatment 1 Intervention

Creating a consistent womb-like sound soundscape to comfort, engage or sedate

Group IV: Muted shaker Experimental Treatment 1 Intervention

If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Group V: Gato box Experimental Treatment 1 Intervention

Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate

Group VI: Contingent singing Experimental Treatment 1 Intervention

Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

A scoping review of 45 articles identified various non-pharmacologic interventions for treating neonatal abstinence syndrome (NAS) that align with occupational therapy practices.

Implementing occupational therapy services in acute care settings could enhance the daily functioning and engagement of infants with NAS, suggesting a proactive approach to their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Management Strategies for Infants With Neonatal Abstinence Syndrome: Scoping Review. Oostlander, SA., Falla, JA., Dow, K., et al.[2020]

Nonpharmacologic management strategies, such as breastfeeding, positioning, and rooming-in, have been shown to effectively reduce symptoms of neonatal abstinence syndrome (NAS) in newborns, leading to shorter hospital stays and lower NAS scores.

The review of 14 articles indicates that these nonpharmacologic approaches can decrease the need for medication, reduce agitation, improve sleep quality, and lessen the severity of NAS symptoms, highlighting their importance in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. Edwards, L., Brown, LF.[2021]

A study comparing 102 infants from community hospitals and 256 from academic centers found no significant differences in length of hospital stay (LOS) or duration of treatment for neonatal abstinence syndrome (NAS), indicating that both settings can effectively manage opioid-exposed infants.

The mean LOS and treatment duration for NAS were similar across both settings, supporting the use of standardized care protocols for managing these infants in either community or academic environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of infants with neonatal abstinence syndrome in community hospitals compared to academic medical centers. Friedman, H., Parkinson, G., Tighiouart, H., et al.[2021]

Breastfeeding and rooming-in for infants with neonatal abstinence syndrome can significantly reduce hospital stays and the need for medication, supporting their use in clinical practice.

While breastfeeding may lead to milder withdrawal symptoms in infants, it does not significantly affect readmission rates compared to formula feeding, highlighting the importance of maintaining breastfeeding and cohabitation for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Breastfeeding and rooming-in in the management of neonatal abstinence syndrome. Scoping review]. Baeza-Gozalo, P., Sola-Cía, S., López-Dicastillo, O.[2023]

Current management practices for infants with neonatal abstinence syndrome are based on outdated standards from the 1970s, lacking empirical evidence to support their effectiveness.

While nonpharmacologic interventions like music therapy and kangaroo care show promise, there is insufficient high-powered research on the efficacy of pharmacologic treatments like buprenorphine in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care of the infant with neonatal abstinence syndrome: strength of the evidence. Maguire, D.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Occupational Therapy Management Strategies for Infants With Neonatal Abstinence Syndrome: Scoping Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of infants with neonatal abstinence syndrome in community hospitals compared to academic medical centers. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

[Breastfeeding and rooming-in in the management of neonatal abstinence syndrome. Scoping review]. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Care of the infant with neonatal abstinence syndrome: strength of the evidence. [2021]