Feasibility of Pulse Oximetry Pre-discharge Screening Implementation for detecting Critical Congenital heart Lesions in newborns in a secondary-level maternity hospital in the Western Cape, South Africa: The ‘POPSICLe’ study

Congenital heart disease (CHD) is common and accounts for more deaths than any other type of congenital malformation. The incidence of significant CHD is said to be 8 9 per 1 000 live births and that of critical congenital heart disease (CCHD), which leads to death or needs surgical intervention before 28 days, approximately 2 3 per 1 000.[1,2] These incidences are constant worldwide, across geographical and ethnic backgrounds and in spite of variations in socioeconomic conditions,[3] but are thought to be underestimated in countries where antenatal booking is delayed or prenatal ultrasound screening not uniformly practised.[4] Early diagnosis currently relies on antenatal fetal anomaly screening and neonatal examination. In South Africa (SA), the vast majority of congenital cardiac lesions are not diagnosed before birth owing to limited antenatal screening for CHD. Cardiac services have improved, and most newborns with CCHD can be diagnosed with echocardiography, stabilised with prostaglandin and treated with surgery or trans-catheter intervention. [5] Without an early diagnosis and appropriate treatment, half of those born with significant CHD will die in infancy or early childhood, a third of them within the first month of life.[4,6] Newborn pulse oximetry (POx) is the first appropriately simple method for universal screening for CHD,[7] the earliest reports having been published in 1995. The rationale is that most CCHD results in a degree of hypoxaemia that would not necessarily produce visible cyanosis and would therefore not be clinically detectable. There is significant evidence that early detection of CCHD through POx monitoring is an effective strategy for reducing morbidity and mortality rates in young children.[8-11] In 2009, the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) released a scientific statement concluding that ‘methods to improve the early detection of CCHD appear warranted’ and called for larger population-based studies on implementation.[5] In 2011, the AAP and the Secretary for Health and Human Services recommended the addition of POx screening to routine newborn screening to detect CCHD in the USA. Most US states have adopted POx screening into routine newborn screening.[12] Many European multicentre studies have been performed, several European countries screen routinely, and the UK is trialling implementation on a large scale.[8-10,13] In a large cost-effectiveness analysis, Ewer et al.[14] concluded that ‘... pulse oximetry is a simple, safe, feasible test that is acceptable to parents and staff and adds value to existing screening. It is likely to identify cases of CCHDs that would otherwise go undetected. It is also likely to be cost-effective given current acceptable thresholds. The detection of other pathologies, such as non-critical CHD and respiratory and infective illnesses, is an additional advantage ...’[14] Feasibility of Pulse Oximetry Pre-discharge Screening Implementation for detecting Critical Congenital heart Lesions in newborns in a secondary-level maternity hospital in the Western Cape, South Africa: The ‘POPSICLe’ study