NASNCT03533985
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
A study testing Song of Kin, Gato box and Ocean disc in people with NAS, run by Icahn School of Medicine at Mount Sinai at 6 sites in United States.
Trial summary
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome. Read more about this study
- Who is it for?
- Ages 28 weeks and older
- Conditions the study is for
- NAS
- What is being tested?
- Song of Kin, Gato box and Ocean disc
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Nov 2017to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elizabeth Barone, MA, MT-BC, CCLS contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, 07601
Naoko Mizutani, MA, 551-996-2714, Naoko.Mizutani@hackensackmeridian.org
Ellen Goldring, 551-996-5146, Naoko.Mizutani@hackensackmeridian.org
- Recruiting
Northwell Health
New Hyde Park, New York, 11040
Greg Razzano, MA, (718) 470-3000, grazzano@northwell.edu
Shawna Vernisie, MA, 718 470-3002, svernisie@northwell.edu
- Recruiting
Tulane University Hospital
New Orleans, Louisiana, 70112
Meghan Howell, MD, FAAP, 504-988-4158, mhowell2@tulane.edu
Rachel Lee, MD, rlee13@tulane.edu
- Recruiting
Mount Sinai West
New York, New York, 10003
Ann Marie Dassler, NP, 973 986 6306, amdassler@yahoo.com
Aimee Telsey, MD, 212 844-8387, amthome@gmail.com
- Recruiting
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
Philadelphia, Pennsylvania, 19102
Flossie Ierardi, MA, (267) 359-5501, sah46@drexel.edu
Scott Horwitz, MA, (267) 359-5572, fmi22@drexel.edu
- Recruiting
Maria Fareri Children's Hospital
Valhalla, New York, 10595
Laurie Park, MA, 914-493-7000
Lance Parton, MD, (914) 493-6640, lanceaparton@yahoo.com
About this study
Official title: The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Read the detailed description
The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.
- Conditions
- NAS
- Being tested
- Song of Kin, Gato box, Ocean disc, Contingent singing, Tonal Vocal holding
- Keywords
- Neonatal Abstinence Syndrome, Music therapy, Attachment, Music medicine, Multi-modal stimulation
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Song of KinBehavioural
Also called Music psychotherapy with parent/s
Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
Gato boxOther
Also called Rhythmic entrainment
Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
Ocean discOther
Also called Timbre entrainment
Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
Contingent singingOther
Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
Tonal Vocal holdingOther
Music therapist will provide a vowel, long held tone, sung without vibrato
Muted shakerOther
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
| Study group | Role | What they receive |
|---|---|---|
| Song of Kin | Experimental | Voice (with or without guitar)- lullaby/ Holding meter Receives: Behavioral: Song of Kin |
| Gato box | Experimental | Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate Receives: Other: Gato box |
| Ocean disc | Experimental | Creating a consistent womb-like sound soundscape to comfort, engage or sedate Receives: Other: Ocean disc |
| Contingent singing | Experimental | Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position) Receives: Other: Contingent singing |
| Tonal Vocal holding | Experimental | Providing a 'blanket of tone' to comfort, engage or sedate Receives: Other: Tonal Vocal holding |
| Muted shaker | Experimental | If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate Receives: Other: Muted shaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured: up to 2 weeks
Respiratory Rate
Measured: up to 2 weeks
O2 sats
Oxygen saturation levels (O2 sats)
Measured: up to 2 weeks
Activity level
The neonatologist or nurse will assess and mark as active/alert, active to stimulation, flaccid, hypertonic, hypotonic, irritable, jittery, lethargic, paralyzed\&medicated, quiet, sedated, or tremors
Measured: up to 2 weeks
Sleep category
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Measured: up to 2 weeks
Feeding (sucking and absorption) category
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Measured: up to 2 weeks
Neonatal Abstinence Scoring (NAS)
The NAS score lists 21 symptoms that are most frequently observed in opiate-exposed infants. Each symptom and its associated degree of severity are assigned a score and the total abstinence score is determined by totalling the score assigned to each symptom over the scoring period. Please provide the full scale info (example 0 (no symptoms) to 10 (severe symptoms)
Measured: up to 2 weeks
Secondary outcomes (1)
Postpartum Bonding Questionnaire (PBQ )
Questionnaire to assess capacity for attachment in both mothers and fathers. 25 item scale with each item rated from always to never. Scoring is based on four categories: impaired bonding scores 0-60, rejection and pathological anger scores 0-35, infant-focused anxiety scores 0-20, and incipient abuse scores 0-10. Total range from 0 (good bonding) to 125 (poor bonding).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Nov 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NASStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Counterbalancing will be achieved by assigning a different order of presentation of conditions for each group. Participants will remain in the study for two weeks, but continue to receive music therapy for the duration of their stay in the NICU.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Loewy, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Loewy, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiKathy Murphy, PhD, Principal investigator, Loyola UniversityAimee Telsey, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533985
- Sponsor's protocol ID
- GCO 16-1991
- Other IDs
- IRB 16-00740
- Status last verified
- Mar 2026
- First submitted
- 11 May 2018
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
PubMed 23589814Loewy J. NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648.
PubMed 25773633Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
PubMed 27561729Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
PubMed 33348423