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The Effect of Music Therapy on Newborns

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ClinicalTrials.gov Identifier: NCT03987165
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Meghan Howell, Tulane University

Brief Summary:
The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Substance Withdrawal, Neonatal Other: Music Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: cross over design with each baby serving as its own control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Music Therapy on Newborns
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Arm Intervention/treatment
Experimental: Music Therapy
Music therapy by a certified music therapist will be delivered to infants over a period of 5 days. There will be two periods of data collection each day, one in the morning and one in the afternoon. Each baby will receive music therapy during one of these time points, with each baby serving as their own control during the second timepoint.
Other: Music Therapy
Music therapy will be conducted once daily using a Song of Kin, a familiar song used to lull the infant to sleep. If no Song of Kin is provided, "Twinkle Twinkle Little Star" will be the default lullaby.

No Intervention: Control



Primary Outcome Measures :
  1. Change in Heart Rate [ Time Frame: Change in average heart rate over the 20 minute sessions (both control and music therapy) ]
    Infant's heart rate before, during and after music therapy and during the control session.

  2. Change in Sleeping Patterns [ Time Frame: Change in phase of sleep over the 20 minute sessions (both control and music therapy) ]
    Basic parameters of sleeping - Type of sleep during control and intervention periods, including but not limited to, active/alert, quiet alert, sleeping. We will monitor time from end of feeding to start of sleep.

  3. Change in Feeding Patterns [ Time Frame: Time from feeding to onset of sleep over the 20 minute session (both control and music therapy) ]
    Time between the end of feeding and the onset of sleeping, with music therapy to be conducted during feeding.

  4. Morphine Utilization [ Time Frame: From day of birth through day of discharge, up to 6 months ]
    Total cumulative dosage of morphine required during the infant's hospitalization as well as the total number of days on morphine. We will also determine the day of the maximum morphine dosage required by the infant.

  5. Total Length of Stay [ Time Frame: From day of birth through day of discharge, up to 6 months ]
    The total number of days the infant was hospitalized, from day of birth to day of discharge from the NICU

  6. Change in Severity of Withdrawal Symptoms [ Time Frame: Through day 30 of treatment with oral opioids ]
    Severity of neonatal withdrawal symptoms as determined by their Finnegan Neonatal Abstinence Scoring Tool (FNAST) scores. This standardized scale is a measure of symptoms of opioid withdrawal experienced by infants with NOWS and scored on a scale from 0 (no symptoms) to 41 (maximum symptoms).



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Admitted to the NICU or newborn nursery
  2. Gestational age 28 weeks or older
  3. No identified hearing disorder
  4. Do not have a diagnosed developmental disability (i.e. Down Syndrome)
  5. Do not have Fetal Alcohol Syndrome
  6. Medically cleared to participate in the study
  7. Parent or legal guardian able/willing to give consent & complete surveys.

Exclusion Criteria:

  1. Gestational age < 28 weeks old
  2. Has an identified hearing disorder
  3. Has diagnosed developmental disability (i.e. Down syndrome)
  4. Has Fetal Alcohol Syndrome
  5. Is not medically cleared to participate in the study
  6. 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): NCT03987165


Contacts
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Contact: Meghan P Howell, MD 504-988-2453 mhowell2@tulane.edu
Contact: Stacy S Drury, MD, PhD 504-988-1438 sdrury@tulane.edu

Locations
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United States, Louisiana
Tulane Lakeside Hospital - Tulane University Recruiting
Metairie, Louisiana, United States, 70001
Contact: Meghan P Howell, MD    504-988-2453    mhowell2@tulane.edu   
Contact: Stacy S Drury, MD, PhD    504-988-1438    sdrury@tulane.edu   
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Meghan P Howell, MD Tulane University

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Responsible Party: Meghan Howell, Assistant Professor, Tulane University
ClinicalTrials.gov Identifier: NCT03987165     History of Changes
Other Study ID Numbers: 1043190
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 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 Meghan Howell, Tulane University:
Neonatal Opioid Withdrawal Syndrome

Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders