Determining the incidence of heart malformations in neonates: A novel and clinically approved solution

BackgroundScreening for critical congenital heart defects should be performed as early as possible and is essential for saving the lives of children and reducing the incidence of undetected adult congenital heart diseases. Heart malformations remain unrecognized at birth in more than 50% of neonates...

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Main Authors: Arash Bordbar, Mandana Kashaki, Maryam Vafapour, Amir A. Sepehri
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-03-01
Series:Frontiers in Pediatrics
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fped.2023.1058947/full
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author Arash Bordbar
Mandana Kashaki
Maryam Vafapour
Amir A. Sepehri
author_facet Arash Bordbar
Mandana Kashaki
Maryam Vafapour
Amir A. Sepehri
author_sort Arash Bordbar
collection DOAJ
description BackgroundScreening for critical congenital heart defects should be performed as early as possible and is essential for saving the lives of children and reducing the incidence of undetected adult congenital heart diseases. Heart malformations remain unrecognized at birth in more than 50% of neonates at maternity hospitals. Accurate screening for congenital heart malformations is possible using a certified and internationally patented digital intelligent phonocardiography machine. This study aimed to assess the actual incidence of heart defects in neonates. A pre-evaluation of the incidence of unrecognized severe and critical congenital heart defects at birth in our well-baby nursery was also performed.MethodsWe conducted the Neonates Cardiac Monitoring Research Project (ethics approval number: IR-IUMS-FMD. REC.1398.098) at the Shahid Akbarabadi Maternity Hospital. This study was a retrospective analysis of congenital heart malformations observed after screening 840 neonates. Using a double-blind format, 840 neonates from the well-baby nursery were randomly chosen to undergo routine clinical examinations at birth and digital intelligent phonocardiogram examinations. A pediatric cardiologist performed echocardiography for each neonate classified as having abnormal heart sounds using an intelligent machine or during routine medical examinations. If the pediatric cardiologist requested a follow-up examination, then the neonate was considered to have a congenital heart malformation, and the cumulative incidence was calculated accordingly.ResultsThe incidence of heart malformations in our well-baby nursery was 5%. Furthermore, 45% of heart malformations were unrecognized in neonates at birth, including one critical congenital heart defect. The intelligent machine interpreted innocent murmurs as healthy heart sound.ConclusionWe accurately and cost-effectively screened for congenital heart malformations in all neonates in our hospital using a digital intelligent phonocardiogram. Using an intelligent machine, we successfully identified neonates with CCHD and congenital heart defects that could not be detected using standard medical examinations. The Pouya Heart machine can record and analyze sounds with a spectral power level lower than the minimum level of the human hearing threshold. Furthermore, by redesigning the study, the identification of previously unrecognized heart malformations could increase to 58%.
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spelling doaj.art-206ac520e3594383bd0d866e740f6b792023-03-15T05:51:53ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602023-03-011110.3389/fped.2023.10589471058947Determining the incidence of heart malformations in neonates: A novel and clinically approved solutionArash Bordbar0Mandana Kashaki1Maryam Vafapour2Amir A. Sepehri3Shahid Akbarabadi Clinical Research & Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, IranShahid Akbarabadi Clinical Research & Development Unit (ShACRDU), Iran University of Medical Sciences (IUMS), Tehran, IranDepartment of Pediatrics, Ali-Asghar Children’s Hospital, Iran University of Medical Sciences, Tehran, IranBiomedical R&D Department, CAPIS Research and Development Co., Mons, BelgiumBackgroundScreening for critical congenital heart defects should be performed as early as possible and is essential for saving the lives of children and reducing the incidence of undetected adult congenital heart diseases. Heart malformations remain unrecognized at birth in more than 50% of neonates at maternity hospitals. Accurate screening for congenital heart malformations is possible using a certified and internationally patented digital intelligent phonocardiography machine. This study aimed to assess the actual incidence of heart defects in neonates. A pre-evaluation of the incidence of unrecognized severe and critical congenital heart defects at birth in our well-baby nursery was also performed.MethodsWe conducted the Neonates Cardiac Monitoring Research Project (ethics approval number: IR-IUMS-FMD. REC.1398.098) at the Shahid Akbarabadi Maternity Hospital. This study was a retrospective analysis of congenital heart malformations observed after screening 840 neonates. Using a double-blind format, 840 neonates from the well-baby nursery were randomly chosen to undergo routine clinical examinations at birth and digital intelligent phonocardiogram examinations. A pediatric cardiologist performed echocardiography for each neonate classified as having abnormal heart sounds using an intelligent machine or during routine medical examinations. If the pediatric cardiologist requested a follow-up examination, then the neonate was considered to have a congenital heart malformation, and the cumulative incidence was calculated accordingly.ResultsThe incidence of heart malformations in our well-baby nursery was 5%. Furthermore, 45% of heart malformations were unrecognized in neonates at birth, including one critical congenital heart defect. The intelligent machine interpreted innocent murmurs as healthy heart sound.ConclusionWe accurately and cost-effectively screened for congenital heart malformations in all neonates in our hospital using a digital intelligent phonocardiogram. Using an intelligent machine, we successfully identified neonates with CCHD and congenital heart defects that could not be detected using standard medical examinations. The Pouya Heart machine can record and analyze sounds with a spectral power level lower than the minimum level of the human hearing threshold. Furthermore, by redesigning the study, the identification of previously unrecognized heart malformations could increase to 58%.https://www.frontiersin.org/articles/10.3389/fped.2023.1058947/fullcongenital heart malformationscongenital heart diseasescritical congenital heart defectsinnocent murmursintelligent phonocardiogramintelligent phonocardiography
spellingShingle Arash Bordbar
Mandana Kashaki
Maryam Vafapour
Amir A. Sepehri
Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
Frontiers in Pediatrics
congenital heart malformations
congenital heart diseases
critical congenital heart defects
innocent murmurs
intelligent phonocardiogram
intelligent phonocardiography
title Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
title_full Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
title_fullStr Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
title_full_unstemmed Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
title_short Determining the incidence of heart malformations in neonates: A novel and clinically approved solution
title_sort determining the incidence of heart malformations in neonates a novel and clinically approved solution
topic congenital heart malformations
congenital heart diseases
critical congenital heart defects
innocent murmurs
intelligent phonocardiogram
intelligent phonocardiography
url https://www.frontiersin.org/articles/10.3389/fped.2023.1058947/full
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