NCT07542509 Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]
| NCT ID | NCT07542509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Cardiac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-07-18 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 phase will be followed by a prospective validation phase, in which the classifier will be applied to assess its diagnostic performance. This phase will also evaluate the economic impact of the digital screening approach compared with standard practice. During the derivation phase, neonates with known cardiovascular status, as determined by prior echocardiographic assessment (including both healthy subjects and those with congenital heart disease), will be enrolled. Heart sounds will be recorded in a quiet environment under standard clinical conditions, without sedation. Digital recordings will be stored in WAV format and analyzed to develop a binary classification algorithm capable of distinguishing healthy from pathological cases. Following development, the classifier will be prospectively applied to a validation cohort of neonates undergoing conventional cardiovascular screening (clinical examination and pre- and post-ductal pulse oximetry), followed by classification using the digital tool under investigation. All participants will subsequently undergo confirmatory echocardiography. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated for both the digital and conventional screening modalities. Furthermore, the number of missed pathological cases and the number of unnecessary second-level investigations resulting from false-positive findings will be used to define the economic benefit profile of the proposed screening strategy. Monte Carlo simulation techniques will be employed to extrapolate these findings at the national level, using ISTAT data on birth rates and disease prevalence. It is anticipated that the development of a digital classifier for the binary classification of neonatal heart sounds will be feasible. Moreover, it is expected that this tool will demonstrate superior diagnostic performance compared with current neonatal screening strategies, with beneficial implications not only for the accurate identification of affected and healthy neonates but also for reducing overall healthcare costs associated with missed diagnoses and inappropriate overdiagnosis.
Eligibility 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
Contact & Investigator
Gabriele Egidy Assenza, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi
Frequently Asked Questions
Who can join the NCT07542509 clinical trial?
This trial is open to participants of all sexes, aged 7 Days or older, up to 30 Days, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07542509 currently recruiting?
Yes, NCT07542509 is actively recruiting participants. Contact the research team at gabriele.egidyassenza@aosp.bo.it for enrollment information.
Where is the NCT07542509 trial being conducted?
This trial is being conducted at Bologna, Italy, Milan, Italy, Roma, Italy, Roma, Italy and 1 additional location.
Who is sponsoring the NCT07542509 clinical trial?
NCT07542509 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Gabriele Egidy Assenza, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna Sant'Orsola-Malpighi. The trial plans to enroll 1,000 participants.