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Study identifier: NCT07542509 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]

Condition: Cardiac Disease · Auscultation of Heart · Machine Learning  ·  Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

PhaseN/A
Planned participants1000
Who can joinAll sexes, 7 Days to 30 Days
Healthy volunteersYes

About this study

Neonatal screening procedures for potentially life-threatening congenital cardiovascular diseases (i.e., duct-dependent systemic or pulmonary circulation), currently implemented at the national level, rely primarily on cardiovascular physical examination performed by a neonatologist. More recently, this approach has been complemented by the assessment of hemoglobin oxygen saturation at both the upper and lower extremities (pre- and post-ductal saturation) in order to improve diagnostic sensitivity, although this practice has not yet been uniformly adopted nationwide. Converging evidence indicates that these screening strategies are affected by significant limitations in both sensitivity (failure to identify affected individuals) and specificity (false-positive findings in healthy subjects). These limitations are associated with substantial overall costs for the healthcare system. Failure to correctly identify affected neonates may result in increased morbidity and mortality, whereas overdiagnosis leads to unnecessary second-level diagnostic investigations and imposes a considerable psychological burden on families, who remain understandably anxious until diagnostic confirmation is achieved. The aim of the present research project (proof-of-concept study) is to develop a digital classifier capable to categorize heart sounds with commercially available digital stethoscopes into a binary classification system distinguishing physiological from pathological sounds. The derivation…

This description comes directly from the study's public registry record.

Talk to the study team

Gabriele Egidy Assenza, MD  ·  0512149072  ·  gabriele.egidyassenza@aosp.bo.it

Always discuss trial participation with your own doctor first.

Locations (5)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-MalpighiBologna, BO, ItalyRecruiting
Politecnico di MilanoMilan, Michigan, ItalyActive Not Recruiting
Policlinico Umberto I di RomaRoma, RM, ItalyRecruiting
IRCCS Ospedale Pediatrico Bambin Gesu', RomaRoma, RM, ItalyRecruiting
Azienda Ospedaliera Monaldi di NapoliNaples, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07542509