Digital diagnosis of newborn heart sounds
Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 7 Days to 30 Days |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 5 sites (Bologna, BO and 4 other locations) |
| Trial ID | NCT07542509 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, BO and 4 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi — Bologna, Bo, Italy (Recruiting)
- Politecnico di Milano — Milan, Michigan, Italy (Active_not_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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.