Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

NAS Clinical Trial

Official title:

The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533985
• Other study ID #: GCO 16-1991
• Secondary ID: IRB 16-00740
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Joanne Loewy, DA, LCAT, MT-BC
• Phone: 212-420-3484
• Email: joanne.loewy[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• NAS
• Neonatal Abstinence Syndrome

Intervention

Behavioral:
• Song of Kin
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.

Other:
• Gato box
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 disc
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 singing
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 holding
Music therapist will provide a vowel, long held tone, sung without vibrato
• Muted shaker
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Locations

Country	Name	City	State
United States	Joseph M. Sanzari Children's Hospital	Hackensack	New Jersey
United States	Northwell Health	New Hyde Park	New York
United States	Tulane University Hospital	New Orleans	Louisiana
United States	Mount Sinai West	New York	New York
United States	Drexel University/Hahnemann Hospital-College of Nursing and Health Professions	Philadelphia	Pennsylvania
United States	Maria Fareri Children's Hospital	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bieleninik 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. — View Citation

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. — View Citation

Loewy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate		up to 2 weeks
Primary	Respiratory Rate		up to 2 weeks
Primary	O2 sats	Oxygen saturation levels (O2 sats)	up to 2 weeks
Primary	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	up to 2 weeks
Primary	Sleep category	The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.	up to 2 weeks
Primary	Feeding (sucking and absorption) category	The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)	up to 2 weeks
Primary	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)	up to 2 weeks
Secondary	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).	Baseline

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