Pulse Oximetry Screening in Early Detection of Critical Congenital Heart Disease in Asymptomatic Neonates: A Cohort Study

Objective Pulse oximetry screening (POxS) for critical congenital heart disease (CCHD) in neonates is an efficient life-saving approach. POxS for neonates is a standard of care in developed countries, but there is limited data from India. This study evaluates the effectiveness of POxS in detecting CCHD among asymptomatic neonates at a tertiary care centre in India. Methods This prospective cohort study was conducted over 3 years, starting in March 2021, at a tertiary-level teaching hospital in South India. Healthy neonates who completed 35 weeks of gestation and were admitted to the postnatal ward were enrolled. Neonates underwent POxS for CCHD at 24-48 h of age with a single rescreen protocol. Baseline characteristics with anthropometry, POxS details, echocardiography and subsequent management were collected. Follow-up details and outcomes of CCHD were collected. To identify false-negative screens, echocardiographic details of infants who underwent echocardiography based on clinical examination findings during hospital stay or on subsequent follow-up were collected. All infants were followed for at least 6 months of age through follow-up in the outpatient department. Sensitivity, specificity and predictive values of POxS in the detection of CCHD were calculated. Results Of the 7,277 eligible neonates delivered during the study period, 27 were excluded in view of antenatally detected anomalies or syndromic association. Among the 7,250 neonates enrolled, 14 neonates failed POxS and CCHD was diagnosed in 9 neonates. One case of truncus arteriosus missed by POxS was diagnosed in follow-up. Five neonates required immediate cardiac intervention in the neonatal period. One neonate with hypoplastic left heart syndrome succumbed during the neonatal period and two cases expired during follow-up. The sensitivity, specificity, positive and negative predictive values of POxS in detecting CCHD were 90.00% (55.5-99.75), 99.93% (99.84-99.98), 64.3% (42.3-81.6) and 99.9% (99.91%-100%), respectively. Conclusions POxS is highly specific in early identification of neonates with CCHD and early intervention is possible in low- and middle-income countries.