Automated Algorithm Based Analysis of Phonocardiograms of Newborns
Condition: Heart Murmurs; Mitral Valve Prolapse; Systolic Murmurs
MeSH terms: Mitral Valve Prolapse; Prolapse; Systolic Murmurs; Heart Murmurs
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this double-blind pivotal clinical utility study is to determine on a large
      patient population whether heart murmurs can be reliably detected with high sensitivity and
      specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred
      to as computer aided auscultation (CAA)).

      Each patient is auscultated and diagnosed independently by a medical specialist.
      Additionally, for each patient, an echocardiogram is performed as the gold-standard for
      determining heart pathologies. The CAA results are compared to the findings of the medical
      professionals as well as to the echocardiogram findings.

      Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically
      diagnose pathological heart murmurs in premature babies and newborns with at least the same
      accuracy as experienced medical specialists.
    

Detailed description: 
      The following registry procedures and quality factors have been implemented:

        -  Quality assurance plan, including

             -  data validation

             -  proper registration procedures

             -  regular site monitoring

             -  regular auditing

        -  Data checks to compare data entered into the registry against predefined rules for range
           or consistency with other data fields in the registry.

        -  Source data verification to assess the accuracy, completeness, or representativeness of
           registry data by comparing the data to external data sources (medical records and paper
           case report forms).

        -  Standard Operating Procedures to address registry operations and analysis activities,
           such as patient recruitment, data collection, data management, data analysis, reporting
           for adverse events, and change management.

        -  Sample size assessment to specify the number of participants or participant years
           necessary to demonstrate an effect.

        -  Statistical analysis plan describing the analytical principles and statistical
           techniques to be employed in order to address the primary and secondary objectives, as
           specified in the study protocol or plan.

        -  Plan for missing data to address situations where variables are reported as missing,
           unavailable, "non-reported," uninterpretable, or considered missing because of data
           inconsistency or out-of-range results.
    

Intervention name(s): Computer aided auscultation (CAA)
Intervention type(s): Device
Other intervention name(s): Phonocardiogram analysis; Automated heart murmur classification; Murmur screening
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Premature babies and newborns stationed at the department of neonatology
      
Keywords: Computer aided auscultation (CAA); Phonocardiogram analysis; Murmur detection; Heart auscultation