ArticlesPulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study
Introduction
Congenital heart defects are a leading cause of infant death in high-income countries, and affect eight of 1000 livebirths.1 About one to two per 1000 newborn babies have critical congenital heart disease, which is defined as disease that causes death or needs invasive intervention in the neonatal period, and neonates with this disease benefit most from early detection.2 During the past few years, several pioneering studies have provided compelling evidence for the addition of pulse oximetry to fetal ultrasound screening and routine clinical assessment as a complementary method for detection of critical congenital heart disease.3, 4, 5, 6, 7, 8 In view of strong supporting evidence, this method was considered in several high-income countries to detect critical disease.9, 10, 11, 12 However, many children born with simple but serious congenital heart disease (such as large ventricular septal defects) in low-income countries cannot be recognised early enough to avoid irreversible pulmonary vascular disease.13, 14 Therefore, all major congenital heart diseases (those causing death or requiring invasive intervention during infancy) should be regarded as main targets of neonatal screening in low-income countries.
Although favourable outcomes of studies of pulse oximetry in high-income countries might not predict similar success in low-income countries, we believed that lower prenatal and postnatal detection rates in low-income countries would increase the benefit of screening. However, pulse oximetry should not preclude routine clinical assessment, which can sometimes detect a serious congenital heart disease before the development of hypoxia. China is the largest developing country in the world, with an annual birth rate of roughly 16 million.15 Nearly 5·6% of newborn babies have a birth defect, 27% of which is congenital heart disease.15 Because of a paucity of large-scale screening for neonatal congenital heart disease in low-income countries, whether pulse oximetry plus clinical assessment could lead to major progress in timely detection of serious disease in these countries might be difficult to establish. We aimed to assess the feasibility and reliability of pulse oximetry plus clinical assessment for detection of major congenital heart disease, especially critical congenital heart disease, in newborn babies in China.
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Study design and participants
We did a pilot study in three hospitals in Shanghai (Songjiang Maternity Hospital, Minhang Maternity Hospital, and Songjiang District Central Hospital) between Feb 1, 2011, and July 31, 2011, to assess the practicability and accuracy of pulse oximetry plus clinical assessment screening for the detection of congenital heart disease in newborn babies. The three hospitals were selected as being representative of most birthing facilities in China. Findings of the pilot study showed that pulse
Results
During the pilot study, 6785 livebirths were recorded in the three hospitals. Of these, 35 newborn babies presented with tachypnoea or cyanosis before screening; the symptoms were caused by a lung problem, and no congenital heart disease was detected. The remaining 6750 newborn babies were asymptomatic at the time of screening. The median age of screening was 43 h (range 2–97). Pulse oximetry test was done for a mean of 1·6 min (range 0·8–4·0). Pulse oximetry plus clinical assessment detected
Discussion
In high-income countries about 13–48% of newborn babies with critical congenital heart disease leave hospital undiagnosed;17 however, no population-based data have been reported in low-income countries. In our study, if pulse oximetry had not been incorporated into the routine care, 33 of 179 (18%) newborn babies with critical congenital heart disease would have left the hospital undiagnosed. However, this figure is likely to be higher in birthing hospitals in which clinicians are not well
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