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Trial record 3 of 15 for:    Loewy

Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

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ClinicalTrials.gov Identifier: NCT03533985
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
NAS Behavioral: Song of Kin Other: Gato box Other: Ocean disc Other: Contingent singing Other: Tonal Vocal holding Other: Muted shaker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
Primary Purpose: Treatment
Official Title: The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Song of Kin
Voice (with or without guitar)- lullaby/ Holding meter
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 Name: Music psychotherapy with parent/s

Experimental: Gato box
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd 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
Other Name: Rhythmic entrainment

Experimental: Ocean disc
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Other: 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.
Other Name: Timbre entrainment

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

Experimental: Tonal Vocal holding
Providing a 'blanket of tone' to comfort, engage or sedate
Other: Tonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato

Experimental: 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
Other: 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




Primary Outcome Measures :
  1. Heart Rate [ Time Frame: up to 2 weeks ]
  2. Respiratory Rate [ Time Frame: up to 2 weeks ]
  3. O2 sats [ Time Frame: up to 2 weeks ]
    Oxygen saturation levels (O2 sats)

  4. Activity level [ Time Frame: up to 2 weeks ]
    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

  5. Sleep category [ Time Frame: up to 2 weeks ]
    The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.

  6. Feeding (sucking and absorption) category [ Time Frame: up to 2 weeks ]
    The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)

  7. Neonatal Abstinence Scoring (NAS) [ Time Frame: up to 2 weeks ]
    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)


Secondary Outcome Measures :
  1. Postpartum Bonding Questionnaire (PBQ ) [ Time Frame: Baseline ]
    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).



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Ages Eligible for Study:   28 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533985


Contacts
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Contact: Joanne Loewy, DA, LCAT, MT-BC 212-420-3484 joanne.loewy@mountsinai.org
Contact: Jasmine Edwards, MA, MT-BC 212-420-2743 Jasmine.Edwards1@mountsinai.org

Locations
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United States, Louisiana
Tulane University Hospital Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Meghan Howell, MD, FAAP    504-988-4158    mhowell2@tulane.edu   
Contact: Rachel Lee, MD       rlee13@tulane.edu   
Principal Investigator: Stacy Drury, MD, PhD         
United States, New Jersey
Joseph M. Sanzari Children's Hospital Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Naoko Mizutani, MA    551-996-2714    Naoko.Mizutani@hackensackmeridian.org   
Contact: Ellen Goldring    551-996-5146    Naoko.Mizutani@hackensackmeridian.org   
Sub-Investigator: Ellen Goldring, MA         
United States, New York
Northwell Health Recruiting
New Hyde Park, New York, United States, 11040
Contact: Greg Razzano, MA    718-470-3000    grazzano@northwell.edu   
Contact: Shawna Vernisie, MA    718 470-3002    svernisie@northwell.edu   
Sub-Investigator: Shawna Vernisie, MA         
Mount Sinai West Recruiting
New York, New York, United States, 10003
Contact: Ann Marie Dassler, NP    973-986-6306    amdassler@yahoo.com   
Contact: Aimee Telsey, MD    212 844-8387    amthome@gmail.com   
Sub-Investigator: Jasmine Edwards, MA         
Maria Fareri Children's Hospital Recruiting
Valhalla, New York, United States, 10595
Contact: Laurie Park, MA    914-493-7000      
Contact: Lance Parton, MD    (914) 493-6640    lanceaparton@yahoo.com   
Sub-Investigator: Laurie Park, MA         
United States, Pennsylvania
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Flossie Ierardi, MA    267-359-5501    sah46@drexel.edu   
Contact: Scott Horwitz, MA    (267) 359-5572    fmi22@drexel.edu   
Sub-Investigator: Flossie Ierardi, MA         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joanne Loewy, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: Kathy Murphy, PhD Loyola University
Study Director: Aimee Telsey, MD Icahn School of Medicine at Mount Sinai

Additional Information:
Publications:
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03533985     History of Changes
Other Study ID Numbers: GCO 16-1991
IRB 16-00740 ( Other Identifier: Icahn School of Medicine at Mount Sinai )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Neonatal Abstinence Syndrome
Music therapy
Attachment
Music medicine
Multi-modal stimulation
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders