CompletedNot Applicable

The Effect of Music Therapy on Newborns

United States42 participantsStarted 2018-12-10

Plain-language 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).

Who can participate

Age range

1 Minute – 1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Admitted to the NICU or newborn nursery
. Corrected gestational age 34 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
. Parent or legal guardian able/willing to give consent \& complete surveys.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Heart Rate

Timeframe: Change in average heart rate over the 20 minute sessions (both control and music therapy)

Change in Heart Rate Variability

Timeframe: Change in average heart rate variability over the 20 minute sessions (both control and music therapy)

Change in Sleeping Patterns

Timeframe: Change in phase of sleep over the 20 minute sessions (both control and music therapy)

Change in Feeding Patterns

Timeframe: Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)

Morphine Utilization

Timeframe: From day of birth through day of discharge, up to 6 months

Total Length of Stay

Timeframe: From day of birth through day of discharge, up to 6 months

Trial details

NCT IDNCT03987165

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-07

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials

Plain-language summary

Who can participate

Age range

1 Minute – 1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Admitted to the NICU or newborn nursery
. Corrected gestational age 34 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
. Parent or legal guardian able/willing to give consent \& complete surveys.

Exclusion criteria

What they're measuring

Change in Heart Rate

Timeframe: Change in average heart rate over the 20 minute sessions (both control and music therapy)

Change in Heart Rate Variability

Timeframe: Change in average heart rate variability over the 20 minute sessions (both control and music therapy)

Change in Sleeping Patterns

Timeframe: Change in phase of sleep over the 20 minute sessions (both control and music therapy)

Change in Feeding Patterns

Timeframe: Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)

Morphine Utilization

Timeframe: From day of birth through day of discharge, up to 6 months

Total Length of Stay

Timeframe: From day of birth through day of discharge, up to 6 months