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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Abstinence Syndrome Substance Withdrawal, Neonatal||Other: Music Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||cross over design with each baby serving as its own control|
|Masking:||None (Open Label)|
|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|
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|
- 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.
- 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.
- 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.
- 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.
- 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
- 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).
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
|Contact: Meghan P Howell, MDfirstname.lastname@example.org|
|Contact: Stacy S Drury, MD, PhDemail@example.com|
|United States, Louisiana|
|Tulane Lakeside Hospital - Tulane University||Recruiting|
|Metairie, Louisiana, United States, 70001|
|Contact: Meghan P Howell, MD 504-988-2453 firstname.lastname@example.org|
|Contact: Stacy S Drury, MD, PhD 504-988-1438 email@example.com|
|Principal Investigator:||Meghan P Howell, MD||Tulane University|