Background: Screening for critical congenital heart defects should be done as early as possible and is essential to save lives and reduce the incidence of undetected adult congenital heart diseases. Over 50% of neonates with heart malformations remain unrecognized at birth. Accurate screening for congenital heart malformations is achievable using a certified and internationally patented digital intelligent phonocardiography machine. This study aimed to assess the actual incidence of newborn heart defects in a well-baby nursery and evaluate digital intelligent phonocardiogram screening for critical congenital heart defects.
Methods: We conducted the “Neonates Cardiac Monitoring Research Project” (ethics approval number: IR-IUMS-FMD. REC.1398.098) at the Shahid Akbarabadi Maternity Hospital. This study is a retrospective analysis of screening congenital heart malformation in 840 neonates. Randomly, 840 neonates from the well-baby nursery underwent standard clinical examinations at birth and digital intelligent phonocardiogram examination in a double-blinded format. Pediatric cardiologist performed echocardiography for each neonate classified as abnormal using the intelligent machine or routine medical examinations. If a follow up was demanded by the pediatric cardiologist, the neonate was considered as having a congenital heart malformation and the cumulative incidence proportion was calculated accordingly.
Results: The incidence of heart malformations in the well-baby nursery was 5%, and 44% of neonates with heart malformations were unrecognized at birth based on the standard medical examination results, including those with critical congenital heart defects (CCHD). An intelligent phonocardiogram recognized 100% of neonates with heart malformations.
Conclusion: We accurately and cost-effectively screened for congenital heart malformations in all neonates in our hospital using a digital intelligent phonocardiogram. We detected neonates with CCHD and congenital heart defects using an intelligent machine; these could not be detected using standard medical examinations. In addition, the intelligent machine interpreted innocent murmurs as healthy heart sounds.