Clinical trial NCT02105480: Automated Algorithm Based Analysis of Phonocardiograms of Newborns
Official title: Automated Algorithm Based Analysis of Phonocardiograms of Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Murmurs
Mitral Valve Prolapse
Systolic Murmurs
Keywords: Computer aided auscultation (CAA)
Phonocardiogram analysis
Murmur detection
Heart auscultation
Lead sponsor: CSD Labs GmbH
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature babies and newborns stationed at the department of neonatology

Brief 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.

Eligibility criteria: Inclusion Criteria:

* any premature baby or newborn
* parental approval for study participation

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of correctly diagnosed heart murmurs through locked, independent algorithm based auscultation and traditional stethoscope based auscultation by medical experts
timeFrame: 2 years (expected)
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Hospital
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Gerhard Pichler, MD
role: PRINCIPAL_INVESTIGATOR
References: