In the initial pilot study at three hospitals in Shanghai, the authors assessed the accuracy of pulse oximetry plus clinical assessment for detection of congenital heart disease. They then undertook a large, prospective, and multicenter screening study in all consecutive neonates (aged 6–72 h) born at 18 hospitals in China between August 1, 2011, and November 30, 2012. Newborns with positive screen results (either an abnormal pulse oximetry or abnormal clinical assessment) were referred for echocardiography within 24 h of screening. Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for pulse oximetry alone, and in combination with clinical assessment, for detection of major and critical congenital heart disease were calculated.In the pilot study, 6785 consecutive newborns were screened; 46 of 49 cases of asymptomatic major congenital heart disease and eight of eight cases of asymptomatic critical disease were detected by pulse oximetry and clinical assessment. In the prospective multicenter study, they screened 122 738 consecutive new born babies (120 707 asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and 330 major). In asymptomatic newborns, the sensitivity of pulse oximetry plus clinical assessment was 93.2% (95% CI 87.9–96.2) for critical congenital heart disease and 90.2% (86.4–93.0) for major disease. The addition of pulse oximetry to clinical assessment improved sensitivity for detection of critical congenital heart disease from 77.4% (95% CI 70.0–83.4) to 93.2% (87.9–96.2). The false-positive rate for detection of critical disease was 2.7% (3298 of 120 392) for clinical assessment alone and 0.3% (394 of 120 561) for pulse oximetry alone.The authors concluded that pulse oximetry plus clinical assessment is feasible and reliable for the detection of major congenital heart disease in newborns in China. They recommended this combined method to be used in maternity hospitals to screen for congenital heart disease. © 2014, Indian Academy of Pediatrics.