Ascertaining the Prevalence of Heart Malformations in Neonates: A Novel Clinically Approved Solution

Background: It is vital to screen all critical congenital heart defects as early as possible. Screening for congenital heart diseases in neonates is essential for saving children's lives and reducing undetected adult congenital heart diseases. Unfortunately, over 50% of neonates with heart malformations are unrecognized at birth. Accurate screening for congenital heart malformations can be accomplished using the certified and internationally patented digital intelligent phonocardiography machine. The objective of this study is 2-fold: assess the actual prevalence of newborn heart defects in our well-baby nursery and evaluate the digital intelligent phonocardiogram screening for critical congenital heart diseases. Methods: In this study, we have accomplished "The Neonates Cardiac Monitoring Research Project" (ethics approval IR-IUMS-FMD. REC.1398.098) at Shahid Akbarabadi Maternity Hospital. Eight hundred forty neonates from our well-baby nursery have undergone both the standard clinical examinations at birth and the digital intelligent phonocardiogram examination in a double-blinded format. The median age of the neonates was 30,85 hours, and the median weight was 3.12 Kg. In addition, the pediatric cardiologist has performed echocardiography diagnosis for each neonate classified as abnormal either by the intelligent machine or by the standard medical examinations of a neonate. Detailed dataset of the eight hundred neonates’ examinations and printouts of the intelligent machine are available online.Results: We have found that the prevalence of heart malformations in our well-baby nursery is 5%. 44% of the heart malformations are unrecognized at birth through the standard medical examination of the hospital, including neonates with CCHD, Whereas the intelligent phonocardiogram has recognized 100% of neonates with heart malformations.Conclusions: We have accomplished screening for congenital heart malformations in all neonates accurately and cost-effectively in our hospital using the digital intelligent phonocardiogram. The intelligent machine has detected CCHD, where we have not detected it through the hospital's standard medical examinations, including pulse oximetry and the heart sound auscultation. In addition, the intelligent machine interprets innocent murmurs as healthy heart sounds.