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Could a Mother's heartbeat recording soothe preterm babies in the NICU?

NCT ID NCT04757012

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This pilot study tests whether playing a recording of a mother's voice and heartbeat can improve well-being in preterm newborns during their hospital stay. The study uses a special device called Calinange that records and plays back these sounds at a safe volume. Researchers will monitor heart rate, breathing, and other signs to see if the babies are more stable and comfortable.

What this could mean

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

Active substance
Calinange device (maternal voice and heartbeat recording)
What this could lead to
If it works, this could offer a simple, non-drug way to help preterm babies feel more stable and comfortable in the NICU.
What could go wrong
This is a very small pilot study with only 30 babies, so results may not apply to all preterm newborns. The device may not show clear benefits.

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

30 people

The number who actually took part.

Started

Apr 2022

Finished

Jun 2023

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

Up to 7 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: * hospitalised premature newborn in Port-Royal NICU * age between 3 and 6 daysof life * gestational age between 27+0 and 31+6 weeks * hospitalisation in one bed room * parental consents * beneficiaries social security scheme Exclusion Criteria * occurrence of one or more non-inclusion criteria * Non-inclusion Criteria: * Chromosomal abnormality, severe congenital malformation * Toxic substance consumption during pregnancy * Sedative medication in progress, High frequencies ventilation in progress * Neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions * Severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate) * Participation to a other intervention research

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As listed by the trial registrant

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

Preterm newborn

Contacts and locations

Locations

  • NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital

    Paris, 75014, France

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