Newborn Screening for Critical Congenital Heart Disease in a Low-Resource Setting; Research Protocol and Preliminary Results of the Tanzania Pulse Oximetry Study.

BACKGROUND

Critical Congenital Heart Disease (CCHD) is the leading cause of early new-born mortality. Its early detection and intervention is crucial for the survival of affected new-born. Pulse Oximetry (POX) has shown to be one of the feasible, accurate and cost-effective tools in screening CCHD in developed nations, it is yet to be practiced and established as standard of care in a low-resource setting.

OBJECTIVES

This paper reports on the research protocol and preliminary results of an ongoing study regarding the performance of POX in detecting CCHD in new-borns in a low resource setting. Secondary objectives include investigating the burdens of CCHD and outcome at 12 months of age.

METHODS

The Tanzanian Pulse Oximetry Study (TPOXS) is a prospective cohort study which plans to enrol 30,000 mothers and new-borns delivered at two referral hospitals in Tanzania. New-borns are offered POX test 12 hours after birth, those positively undergoes echocardiography examinations. Confirmed with CCHD are placed under observation for up to first birthday.

RESULTS

During a 5-months pilot period, a total of 1,592 infants at the Muhimbili National Hospital, received POX test .65% of them were post-caesarean section and 52% being male. Most babies delivered through Spontaneous Vertex Delivery (SVD) were promptly discharge and did not get screened. The detection-rate of CCHD was 2.5 per 1,000 live births (at 95% confidence interval [CI] 0.9 to 6.7 per 1000 live birth); with a POX false positive rate of 0.6%. Seven false-positive infants out of 10 were found to carry significant other neonatal conditions, including persistent pulmonary hypertension of the new-born, transient tachypnoeic and neonatal sepsis.

CONCLUSION

This paper provides the protocol of the ongoing TPOXS with the preliminary results showing prevalence matching closely the global data. It shows acceptability of POX screening for CCHD in a well-prepared low resource setting.

HIGHLIGHT: This study addresses the utilization of pulse oximeter in detecting critical congenital heart disease (CCHD) in a low-resource setting (such as sub-Saharan African countries).