Chinese Journal of Evidence-Based Pediatrics ›› 2022, Vol. 17 ›› Issue (4): 281-289.DOI: 10.3969/j.issn.1673-5501.2022.04.004

Previous Articles     Next Articles

Appropriate screening timing and locations for neonatal major congenital heart disease: A systematic review and metaanalysis

LU Tianwei1,2,HU Xiaojing2ab,LYU Tianchan2c,MA Xiaojing2ab,ZENG Ziqian2b,ZHAO Zhengshan2b,WANG Dingmei2b,ZHANG Chongfan2d,HUANG Guoying2abe   

  1. 1 Fudan University School of Public Health, Shanghai 200032; 2 Children's Hospital of Fudan University, Shanghai 201102, China; a  National Management Office of Neonatal Screening Project for CHD; b Pediatric Heart Center; c Nursing Department; d Fudan University GRADE Center; e Shanghai Key Laboratory of Birth Defects
  • Received:2022-04-06 Revised:2022-05-22 Online:2022-08-25 Published:2022-09-28
  • Contact: HUANG Guoying, email: gyhuang@shmu.edu.cn; ZHANG Chongfan, email: chongfan_zhang@fudan.edu.cn

Abstract: Background There are many reports on the systematic review of the screening protocols for neonatal congenital heart disease, and the appropriate screening timing and locations for screening are also worthy of attention. Objective To evaluate the diagnostic accuracy and false positive rate of neonatal major congenital heart disease (mCHD) screening at different screening timing and locations. Design Meta-analysis of diagnostic accuracy studies. Methods The literature search and selection have been completed in the development of neonatal CHD screening (NCHDS) guideline. The positive infants in screening were diagnosed as mCHD by cardiac ultrasound (gold standard), or infants with symptoms and signs were confirmed as mCHD in the follow-up by cardiac ultrasound, surgery, or cardiac catheterization (gold standard). The risk of bias and clinical applicability of the included literature were evaluated with the QUADAS-2 scale. The data were extracted and the diagnostic accuracy parameters such as sensitivity, specificity and false positive rate were summarized with the random effect model. Main outcome measures Accuracy of neonatal mCHD screening at different timing and locations. Results Among the 16 studies on the screening timing, 9 were in the postnatal period of ≤ 24 h, 7 were in the period of -48 h, 3 were in the period of -72 h and 3 were in the period of 6-72 h. The sensitivity of neonatal mCHD screening at different timing were 0.788(95%CI:0.600-0.921), 0.579(95%CI:0.378-0.757), 0.586(95%CI:0.369-0.775)and 0.897(95%CI: 0.836-0.937), respectively. And the specificity were 0.985(95%CI: 0.946-0.996, 0.998(95%CI:0.994-0.999), 0.996(95%CI:0.987-0.999)and 0.994(95%CI: 0.983-0.998), respectively. The false positive rates were 0.015 (95%CI: 0.004-0.057), 0.002(95%CI: 0.001-0.006), 0.004(95%CI:0.001-0.016)and 0.006(95%CI:0.002-0.019), respectively. The AUC of neonatal mCHD screening at ≤ 24 h, -48 h, -72h and 6-72 h after birth was 0.916, 0.973, 0.939 and 0.973, respectively. Among the 20 literatures on screening locations, there were 15 in maternity hospitals, 2 in NICU, 2 in out of hospital settings, and 1 in maternity hospitals + NICU. The sensitivity of neonatal mCHD screening was 0.701(95%CI: 0.576-0.802), 0.797(95%CI: 0.675-0.881), 0.571(95%CI: 0.230-0.856) and 0.821(95%CI: 0.555-0.944), respectively. The specificity was 0.995 (95%CI: 0.990-0.998), 0.885 (95%CI: 0.778-0.944), 0.993 (95%CI: 0.988-0.996) and 0.916 (95%CI: 0.189-0.998), respectively. The false positive rates of the neonatal mCHD screening in maternity hospital and NICU were 0.006 (95%CI: 0.003-0.011) and 0.030 (95%CI: 0.001-0.636) respectively, and the AUC were 0.960 and 0.757 respectively. The sensitivity and specificity were 0.817 and 0.996 in the subgroup within 24 h after birth, and 0.680 and 0.996 in the subgroup >24 h after birth. Conclusion When pursuing high sensitivity of screening and accepting high false positive rate, screening within 24 hours after birth can be selected. For low false-positive rate, screening after 24 hours after birth can be selected. Neonatal mCHD screening should be implemented in the maternity hospital for its good accuracy and low false-positive rate.

Key words: Neonate, Major congenital heart disease, Screening timing, Screening locations, Accuracy, False positive rate