Clinical trial NCT03533985: Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
Official title: The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAS
Keywords: Neonatal Abstinence Syndrome
Music therapy
Attachment
Music medicine
Multi-modal stimulation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Heart Rate
timeFrame: up to 2 weeks
measure: Respiratory Rate
timeFrame: up to 2 weeks
measure: O2 sats
timeFrame: up to 2 weeks
measure: Activity level
timeFrame: up to 2 weeks
measure: Sleep category
timeFrame: up to 2 weeks
measure: Feeding (sucking and absorption) category
timeFrame: up to 2 weeks
measure: Neonatal Abstinence Scoring (NAS)
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Postpartum Bonding Questionnaire (PBQ )
timeFrame: Baseline
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Hospital
state: Louisiana
city: Hackensack
country: United States
facility: Joseph M. Sanzari Children's Hospital
state: New Jersey
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: NY
country: United States
facility: Mount Sinai West
state: New York
city: Valhalla
country: United States
facility: Maria Fareri Children's Hospital
state: New York
city: Philadelphia
country: United States
facility: Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
state: Pennsylvania
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne Loewy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loyola University
name: Kathy Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Aimee Telsey, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
citation: Pahl 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.