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Soothing sounds: can live music ease pain in Brain-Injured newborns?

NCT ID NCT06951269

Symptom relief Sponsor: Fundación Santa Fe de Bogota Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study will test whether live, improvised music therapy can lower pain levels in 22 newborns with hypoxic-ischemic encephalopathy (HIE) who are undergoing cooling therapy. Each baby will receive either standard care alone or standard care plus a 15-minute music session after a routine nursing procedure. Pain will be measured using a validated scale, and vital signs, heart rate variability, and brain activity will also be recorded.

What this could mean

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

Active substance
live entrainment-based music therapy
What this could lead to
If it works, this could offer a safe, drug-free way to ease pain and stress in newborns with HIE during cooling treatment.
What could go wrong
This is a very small pilot study (22 infants) testing feasibility, not effectiveness. It may not show clear pain relief or be generalizable to other hospitals.

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 22 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

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

35 to 44 weeks

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: \- Neonates diagnosed with neonatal hypoxic ischemic encephalopathy who have undergone hypothermic therapy as part of their medical treatment. Exclusion Criteria: * Newborns with a gestational age of less than 35 weeks and a birth weight of less than 1800 grams. * Newborns in palliative care or with congenital anomalies with a poor prognosis will also be excluded, as will those with preexisting neurological or genetic conditions. * Furthermore, newborns with a history of serious medical complications that may influence participation in the study, such as pulmonary hypertension or secondary seizure syndrome, will be considered ineligible. * Finally, patients with an N-PASS score of less than -2 will be excluded.

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Conditions

The condition(s) this trial relates to.

Hyperalgesia Pain perinatal asphyxia

As listed by the trial registrant

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

Allodynia Hypothermia neonatal Music therapy Neonates NICU Pain

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospital Fundación Santa Fe de Bogotá

    Bogotá, Bogota D.C., 110221, Colombia

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