Automated Algorithm Based Analysis of Phonocardiograms of Newborns

July 16, 2018 updated by: CSD Labs GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 5 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature babies and newborns stationed at the department of neonatology

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of correctly diagnosed heart murmurs through locked, independent algorithm based auscultation and traditional stethoscope based auscultation by medical experts
Time Frame: 2 years (expected)
Each patient is screened and diagnosed regarding a potential heart murmur by a medical expert through standard stethoscope based auscultation. Heart sounds are recorded using an electronic stethoscope and analyzed and diagnosed independently (with no external input) by a locked algorithm. A final diagnoses for each patient is made by a medical expert by performing an echocardiogram, the gold standard method for heart murmur detection. The diagnoses of both the medical expert and the algorithm are finally compared to the echocardiogram based diagnosis (after completion of patient recruitment).
2 years (expected)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSD Labs GmbH

Investigators

  • Principal Investigator: Gerhard Pichler, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

January 25, 2016

Study Completion (Actual)

January 18, 2017

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRZ02 (AAAPN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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