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Parental voice music may soothe preterm infants and ease NICU stress

NCT ID NCT07295106

Symptom relief Sponsor: Fabrizio Faina Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether playing music made from a parent's voice can help preterm babies in the NICU stay more stable and reduce stress for parents. About 20 preterm infants will each experience both the music therapy and quiet rest, with their heart rate and oxygen levels measured. Parents' stress will also be checked when their baby leaves the hospital. The goal is to see if this approach is helpful and to plan a larger study.

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 20 people

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

Started

Oct 2025

Expected to finish

Mar 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

5 to 15 days

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: * Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment. * Gestational age at birth 28+0 to 36+6 weeks. * Age at enrollment: 5 to 15 days. * Stable vital signs at enrollment per unit policy. * Apgar score at 5 minutes ≥ 7. * Birth weight appropriate for gestational age, between the 50th and 90th percentile. * Written informed consent from parent(s) or legal guardian(s). Exclusion Criteria: * Post-operative status at the time of enrollment. * One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia. * Congenital anomalies. * Hypersensitivity or intolerance to sound. * Maternal history of drug and/or alcohol misuse during pregnancy. * Lack of parental consent.

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Conditions

The condition(s) this trial relates to.

Premature Birth Stress, Psychological

As listed by the trial registrant

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

Infant, premature Stress, psychological

How to take part

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

  1. The places running it

    1 site. 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

  • Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia

    RECRUITING

    Perugia, PG, 06129, Italy

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