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 trial explores how different types of music therapy can help newborns with Neonatal Abstinence Syndrome, a condition affecting babies exposed to drugs in the womb. The study will test six music interventions, including contingent singing and using simple instruments such as the Gato box, muted shaker, ocean disc, and Song of Kin, as well as tonal vocal holding, to determine their effectiveness in comforting and soothing the infants. Newborns who are a good fit for this trial have just been admitted to the NICU after birth, are at least 28 weeks gestational age, and do not have hearing or developmental issues.

As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could significantly improve the well-being of newborns.

Will I have to stop taking my current medications?

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

What prior data suggests that these music therapy interventions are safe for neonates with Neonatal Abstinence Syndrome?

Research shows that music therapy is generally safe for babies. In studies using music therapy to help babies with Neonatal Abstinence Syndrome (NAS), no major negative effects have been reported. These therapies incorporate gentle sounds and singing. Instruments like the muted shaker and gato box produce calming rhythms that align with the baby's natural signals, such as their heartbeat or sucking patterns, to soothe them.

Tonal vocal holding involves the therapist mimicking the baby's cries with their voice, which can help calm the infant. The "Song of Kin" uses familiar lullabies, often sung by a parent, to provide comfort. The ocean disc creates sounds similar to those in the womb, while contingent singing uses playful sounds to engage with the baby.

These methods aim to create a peaceful and supportive environment for newborns. The absence of serious side effects in previous studies suggests that music therapy is well-tolerated and safe for infants with NAS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these music therapy treatments for Neonatal Abstinence Syndrome (NAS) because they offer a non-pharmacological approach to soothing infants, which could reduce the need for medication. Unlike traditional treatments that often involve drugs like morphine or methadone, these methods use sound and rhythm to engage infants' natural responses. Techniques like contingent singing and tonal vocal holding provide comforting auditory stimulation, while instruments like the Gato box and ocean disc recreate womb-like soundscapes that may help calm and stabilize vital signs. This innovative approach not only focuses on comfort and engagement but also aims to minimize potential side effects associated with drug therapies.

What evidence suggests that this trial's music therapy interventions could be effective for Neonatal Abstinence Syndrome?

Research has shown that music therapy can help infants with Neonatal Abstinence Syndrome (NAS). This trial studies various music therapy techniques. For instance, contingent singing, which involves singing in response to a baby's cues, is being tested to help calm infants. The Gato box and Ocean disc are used in separate treatment arms to produce soothing sounds similar to those in the womb, providing comfort. Other arms include the use of muted shaker, tonal vocal holding, and Song of Kin, which involve live music to comfort and engage infants. Overall, these methods aim to reduce distress and improve outcomes for babies with NAS. ^{1 3 6 7 8}

Who Is on the Research Team?

Aimee Telsey, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Kathy Murphy, PhD

Principal Investigator

Loyola University

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03533985

Effect of Music Therapy on Infants With Neonatal ... This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome. Detailed ...

2. mmd.iammonline.com mmd.iammonline.com/index.php/musmed/article/download/519/pdf/0

Music Therapy for Infants with Neonatal Abstinence Syndrome This study measured the effectiveness of recorded sedative music (RSM) and multimodal stimulation (MMS), inclusive of live singing for 25 infants with NAS. The ...

3. clinicaltrial.be clinicaltrial.be/en/details/177439?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Effect of Music Therapy on Infants with Neonatal Abstinen... The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, ...

4. withpower.com withpower.com/trial/phase-neonatal-abstinence-syndrome-10-2017-8ca87

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

5. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1083&context=ysmpa_theses

Recorded Maternal Song to Reduce Crying Duration in ... Additional non-crying secondary outcomes include heart rate, respiratory rate and oxygen saturation measured by pulse oximetry as well as.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551498/

Neonatal Abstinence Syndrome - StatPearls - NCBI Bookshelf Neonatal abstinence syndrome (NAS) is a spectrum of clinical manifestations seen in neonates due to withdrawal secondary to intrauterine drug exposure.

7. ncdhhs.gov ncdhhs.gov/nasadad-nas-fact-sheet-final/open

Neonatal Abstinence Syndrome Neonatal abstinence syndrome (NAS) refers to a treatable condition that newborns experience after chronic exposure to certain substances, primarily opioids, ...

8. ncpoep.org ncpoep.org/guidance-document/neonatal-abstinence-syndrome-overview/neonatal-abstinence-syndrome-nas/

Neonatal Abstinence Syndrome (NAS) Opioid withdrawal in a newborn causes central nervous system excitability or hyperirritability, such as tremors, stiff or rigid muscle tone, and vasomotor signs ...