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Music Therapy for Neonatal Opioid Withdrawal Syndrome

N/A
Recruiting
Led By Meghan P Howell, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the NICU or newborn nursery
No identified hearing disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in phase of sleep over the 20 minute sessions (both control and music therapy)
Awards & highlights

Study Summary

This trial is looking at whether music therapy can help newborns with opioid withdrawal syndrome by reducing symptoms and resource use.

Who is the study for?
This trial is for newborns over 34 weeks gestational age with neonatal opioid withdrawal syndrome, without developmental disabilities like Down Syndrome or hearing disorders. They must be in the NICU or nursery and have a guardian who consents to their participation.Check my eligibility
What is being tested?
The study is testing how music therapy affects infants' behavior (feeding, sleep, withdrawal severity) and body functions (heart rate, breathing). It also looks at whether music therapy can reduce opioid needs and hospital stay duration.See study design
What are the potential side effects?
Since this trial involves music therapy rather than medication, there are no direct side effects expected from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My newborn is in the NICU or nursery.
Select...
I do not have a hearing disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in phase of sleep over the 20 minute sessions (both control and music therapy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in phase of sleep over the 20 minute sessions (both control and music therapy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Feeding Patterns
Change in Heart Rate
Change in Heart Rate Variability
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Music TherapyExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,202 Total Patients Enrolled
Meghan P Howell, MDPrincipal InvestigatorTulane University

Media Library

Music Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03987165 — N/A
Neonatal Abstinence Syndrome Research Study Groups: Control, Music Therapy
Neonatal Abstinence Syndrome Clinical Trial 2023: Music Therapy Highlights & Side Effects. Trial Name: NCT03987165 — N/A
Music Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03987165 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person meet to be included in this clinical trial?

"This medical investigation is enrolling 300 infants aged 1 minute to one month with passive addiction. In order to participate, they must have been admitted in a NICU or newborn nursery, have a corrected gestational age of 34 weeks or more, not suffer from any hearing disorders, no diagnosed developmental disability (such as Down syndrome) and their parent/legal guardian must be willing to consent and complete surveys."

Answered by AI

Does this experiment currently accept new participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation commenced on December 10th 2018 and is currently recruiting participants. 300 individuals must be enrolled from a single site of the study."

Answered by AI

What is the current enrollment capacity for this clinical investigation?

"Affirmative. According to clinicaltrials.gov, the trial that was initially posted on December 10th 2018 is still recruiting volunteers. 300 prospective participants are needed from a single medical site for this experiment."

Answered by AI

Are individuals over 45 years of age eligible to participate in this research?

"This trial is including individuals between 1 year and 1 month old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of Music Therapy on Newborns
2018. "The Effect of Music Therapy on Newborns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03987165.
~5 spots leftby May 2024
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