Elsevier

The Lancet

Volume 384, Issue 9945, 30 August–5 September 2014, Pages 747-754
The Lancet

Articles
Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study

https://doi.org/10.1016/S0140-6736(14)60198-7Get rights and content

Summary

Background

Several pioneering studies have provided evidence for the introduction of universal pulse oximetry screening for critical congenital heart disease. However, whether the benefits of screening reported in studies from high-income countries would translate with similar success to low-income countries is unknown. We assessed the feasibility and reliability of pulse oximetry plus clinical assessment for detection of major congenital heart disease, especially critical congenital heart disease, in China.

Methods

We did a pilot study at three hospitals in Shanghai to assess the accuracy of pulse oximetry plus clinical assessment for detection of congenital heart disease. We made a data collection plan before recruitment. We then undertook a large, prospective, and multicentre screening study in which we screened all consecutive newborn babies (aged 6–72 h) born at 18 hospitals in China between Aug 1, 2011, and Nov 30, 2012. Newborn babies with positive screen results (either an abnormal pulse oximetry or abnormal clinical assessment) were referred for echocardiography within 24 h of screening. We identified false-negative results by clinical follow-up and parents' feedback. We calculated sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for pulse oximetry alone, and in combination with clinical assessment, for detection of major and critical congenital heart disease.

Findings

In the pilot study, 6785 consecutive newborn babies were screened; 46 of 49 (94%) cases of asymptomatic major congenital heart disease and eight of eight (100%) cases of asymptomatic critical disease were detected by pulse oximetry and clinical assessment. In the prospective multicentre study, we screened 122 738 consecutive newborn babies (120 707 asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and 330 major). In asymptomatic newborn babies, the sensitivity of pulse oximetry plus clinical assessment was 93·2% (95% CI 87·9–96·2) for critical congenital heart disease and 90·2% (86·4–93·0) for major disease. The addition of pulse oximetry to clinical assessment improved sensitivity for detection of critical congenital heart disease from 77·4% (95% CI 70·0–83·4) to 93·2% (87·9–96·2). The false-positive rate for detection of critical disease was 2·7% (3298 of 120 392) for clinical assessment alone and 0·3% (394 of 120 561) for pulse oximetry alone.

Interpretation

Pulse oximetry plus clinical assessment is feasible and reliable for the detection of major congenital heart disease in newborn babies in China. This simple and accurate combined method should be used in maternity hospitals to screen for congenital heart disease.

Funding

Key Clinical Research Project sponsored by Ministry of Health, Shanghai Public Health Three-Year Action Plan sponsored by Shanghai Municipal Government, and National Basic Research Project of China.

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.

Section snippets

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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