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AI-Powered stethoscope could save newborns from missed heart defects

NCT ID NCT07542509

Diagnosis Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is developing a computer program that can analyze heart sounds recorded with a digital stethoscope to tell if a newborn's heart is healthy or not. Researchers will record heart sounds from 1,000 babies under 30 days old and use those recordings to train and test the program. The goal is to see if this digital approach can find heart problems more accurately than current newborn screening methods, potentially saving lives and reducing unnecessary worry and costs.

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.

Participants

About 1,000 people

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

Started

Jul 2024

Expected to finish

Jan 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.

Who is studied

The study population will consist of newborns (both male and female). Infants aged 7 to 30 days will be eligible for inclusion, excluding those with a body weight below 1.5 kg and those for whom a diagnostic echocardiogram is not feasible.

Ages

7 to 30 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age \< 30 days * Signed informed consent obtained from parent(s) or representative(s) Exclusion criteria: * Inability to acquire a diagnostic echocardiogram * Weight less than 1.5Kg

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Conditions

The condition(s) this trial relates to.

congenital heart disease heart disorder

As listed by the trial registrant

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

Auscultation of heart Cardiac disease Machine learning

How to take part

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

  1. The places running it

    4 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

  • Azienda Ospedaliera Monaldi di Napoli

    RECRUITING

    Naples, 80131, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi

    RECRUITING

    Bologna, BO, 40138, Italy

  • IRCCS Ospedale Pediatrico Bambin Gesu', Roma

    RECRUITING

    Roma, RM, Italy

  • Policlinico Umberto I di Roma

    RECRUITING

    Roma, RM, 00161, Italy

  • Politecnico di Milano

    ACTIVE_NOT_RECRUITING

    Milan, Michigan, 20133, Italy

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