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Automated Algorithm Based Analysis of Phonocardiograms of Newborns

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ClinicalTrials.gov Identifier: NCT02105480
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
CSD Labs GmbH

Tracking Information
First Submitted Date March 31, 2014
First Posted Date April 7, 2014
Last Update Posted Date July 17, 2018
Actual Study Start Date November 2013
Actual Primary Completion Date January 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2015)
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).
Original Primary Outcome Measures
 (submitted: April 2, 2014)
Number of correctly diagnosed heart murmurs through independent algorithm based auscultation and traditional stethoscope based auscultation by medical experts [ Time Frame: 1.5 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 an 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).
Change History Complete list of historical versions of study NCT02105480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Automated Algorithm Based Analysis of Phonocardiograms of Newborns
Official Title Automated Algorithm Based Analysis of Phonocardiograms of Newborns
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Premature babies and newborns stationed at the department of neonatology
Condition
  • Heart Murmurs
  • Mitral Valve Prolapse
  • Systolic Murmurs
Intervention Device: Computer aided auscultation (CAA)
Other Names:
  • Phonocardiogram analysis
  • Automated heart murmur classification
  • Murmur screening
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 2, 2014)
220
Original Estimated Enrollment Same as current
Actual Study Completion Date January 18, 2017
Actual Primary Completion Date January 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT02105480
Other Study ID Numbers GRZ02 (AAAPN)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CSD Labs GmbH
Study Sponsor CSD Labs GmbH
Collaborators Not Provided
Investigators
Principal Investigator: Gerhard Pichler, MD Medical University of Graz
PRS Account CSD Labs GmbH
Verification Date July 2018