Digital diagnosis of newborn heart sounds
Official title: Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07542509 · Data updated 2026-11-12
This project will test a digital, machine-learning tool that listens to newborn heart sounds to try to detect serious congenital heart problems in the first month of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Days to 30 Days |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 5 sites (Bologna, BO and 4 other locations) |
| Status | Recruiting |
| Started | July 18, 2024 |
| Main results expected | February 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07542509 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Newborns younger than 30 days whose parent(s) consent and who can undergo diagnostic echocardiography, excluding infants weighing less than 1.5 kg.
✕Probably not a fit
Infants who cannot have a diagnostic echocardiogram, weigh under 1.5 kg, or are older than 30 days are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multicenter project will enroll newborns under 30 days at three Italian hospitals to collect digital heart sound recordings, pulse oximetry, and clinical data. Clinicians will obtain diagnostic echocardiography as the reference standard while simultaneous digital auscultation recordings are captured for algorithm development. Recorded data will be used to train and validate a machine-learning model to identify ductal-dependent and other critical congenital heart lesions and compared against standard screening (clinical exam and pulse oximetry). No experimental treatments are administered; the focus is on diagnostic data collection and accuracy testing.
Why it matters
Potential benefit: If successful, this approach could enable earlier and more accurate detection of life-threatening congenital heart defects, reducing missed cases and unnecessary referrals.
How similar studies have gone: Previous work on digital auscultation and AI-assisted heart-sound analysis has shown promise in adults and older children, but robust validation specifically for neonatal ductal-dependent congenital heart disease is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi
Bologna, Bo, Italy Recruiting -
Policlinico Umberto I di Roma
Roma, Rm, Italy Recruiting -
IRCCS Ospedale Pediatrico Bambin Gesu', Roma
Roma, Rm, Italy Recruiting -
Azienda Ospedaliera Monaldi di Napoli
Naples, Italy Recruiting -
Politecnico di Milano
Milan, Michigan, Italy Active not recruiting
Study contacts
- Principal investigator: Gabriele Egidy Assenza, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi
- Study coordinator: Gabriele Egidy Assenza, MD
- Email: gabriele.egidyassenza@aosp.bo.it
- Phone: 0512149072
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.