Objective: Pulse oximetry screening of asymptomatic newborns is suggested as a life-saving procedure for the timely detection of critical congenital heart disease (CHD) in asymptomatic newborns. We evaluated this screening and report cases that demonstrate problems with screening in a non-research setting.
Study design: An elective state-directed public health screening program was evaluated in Middle Tennessee; 14 564 infants were screened after 24 h of age and before discharge. The screening was performed in a non-research setting by nurses at the local hospitals. A parallel investigation of the methods and timing of diagnosis in Middle Tennessee revealed a surprisingly high incidence of antenatal diagnosis (66%).
Result: Using a saturation value of 94% as the defined normal, the positive predictive value was less than 1%, with 112 infants having a false positive case and 1 having a true positive case identified (incidence 1/34 775). The one true positive case was not referred for evaluation. One false-positive case resulted in a costly referral and hospitalization. Antenatal diagnosis when combined with physical examination detected 43 of 44 infants with critical CHD during the year-long evaluation.
Conclusion: Before universal screening can be implemented, a system of care must be defined to address the educational and referral issues raised by this report.