Diagnostic accuracy of combined screening algorithm for early detection of congenital heart disease among term newborns in India.

Abstract

Objective: To determine the validity of a screening algorithm based on combination of clinical examination and pulse oximetry, for early detection of congenital heart disease (CHD) in term newborns. CHD is the most frequent major congenital anomaly, with prevalence of 6-12 per 1000 live births. Clinical examination alone may fail to detect CHD in more than 50% of affected newborns. Recent studies have concluded that pulse oximetry has a high sensitivity and specificity as a screening tool for critical CHD.

Setting: JSS Hospital, Mysuru, Karnataka, India.

Methods: In this prospective observational study, all term neonates delivered at the hospital were included. The screening algorithm consisted of seven clinical parameters and pulse oximetry screening guidelines recommended by the American Academy of Paediatrics. Term newborns with the presence of any one of the above parameters in the algorithm were considered screen-positive. Echocardiography was done in all screen positives. Newborns were classified into those with and without CHD, based on echocardiography findings at birth and clinical examination and echocardiography findings at follow-up at 6 weeks.

Results: Among 1009 term neonates included in the study, CHD was detected in 57 (5.6%) with cyanotic CHD in 12. The sensitivity and specificity of combined screening to detect CHD was 71.93% and 95.8%, respectively. The positive predictive value was 50.62% and the negative predictive value was 98.28%.

Conclusion: Screening for CHD with a simple comprehensive algorithm, integrating clinical evaluation and pulse oximetry, has moderate sensitivity and high specificity in detecting CHD in term newborns. Further work is needed to evaluate this form of screening.