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Lullabies as medicine: can music ease opioid withdrawal in newborns?

NCT ID NCT03533985

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study tests whether music therapy can help newborns who are withdrawing from opioids they were exposed to before birth. Researchers will try six different music-based approaches, including parent-sung lullabies and rhythmic sounds, to see if they calm the babies and improve vital signs, sleep, and feeding. The goal is to find a gentle, non-drug way to ease withdrawal symptoms in the neonatal intensive care unit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
music therapy interventions including Song of Kin (parent-led lullabies) and rhythmic entrainment (Gato box)
What this could lead to
If effective, music therapy could offer a drug-free way to soothe withdrawal symptoms in newborns and reduce the need for medication.
What could go wrong
This is a small pilot study, so results may not be definitive. Music therapy may not significantly improve outcomes, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NAS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Drexel University/Hahnemann Hospital-College of Nursing and Health Professions

    RECRUITING

    Philadelphia, Pennsylvania, 19102, United States

  • Joseph M. Sanzari Children's Hospital

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Maria Fareri Children's Hospital

    RECRUITING

    Valhalla, New York, 10595, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10003, United States

  • Northwell Health

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Tulane University Hospital

    RECRUITING

    New Orleans, Louisiana, 70112, United States

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