Key result
Newborn CHD screening linked to ~62% lower CHD-related infant mortality.
Why the study?
To examine the implementation of a newborn congenital heart disease screening program within healthcare systems in Jiangsu Province using real-world data and systematically assess its effectiveness.
Does a newborn congenital heart disease screening program reduce infant and under-five mortality due to CHD in live births?
Observational (n=2,512,635)
Yes
Does a newborn congenital heart disease screening program reduce infant and under-five mortality due to CHD in live births?
Implementation of a province-wide newborn screening program for congenital heart disease was associated with a significant reduction in infant and under-five mortality rates due to CHD.
May support newborn CHD screening programs; extends observational data but leaves causality unproven.
BACKGROUND: Since 2019, Jiangsu province has implemented newborn screening for congenital heart disease (CHD). As of 2023, 591 hospitals (584 public or private midwifery institutions, 7 specialized hospitals for children) in Jiangsu province conduct CHD screening, including 132 with diagnostic capabilities and 21 with treatment facilities, ensuring comprehensive coverage of 13 prefecture-level cities, 95 counties (19 counties, 21 county-level cities, 55 districts) in Jiangsu Province. This study aims to examine the implementation of the newborn CHD screening program within Jiangsu Province's healthcare systems using real-world clinical data and to assess its effectiveness in patient care systematically. Additionally, we seek to offer data-driven recommendations for advancing the development of patient risk screening tools. METHODS: Our study analyzed dataset from live births at midwifery institutions across Jiangsu province from 2019 to 2023. All newborns aged 6-72 h were screened by trained medical staff using the dual-index method. Newborns diagnosed without CHD or screened negative were tracked through the Child Health Management program, a basic public health service for children under 7 years of age in China. Newborns testing positive were referred to a diagnostic institution for echocardiographic assessment, and those with confirmed CHDs were directed to a treatment facility for further evaluation and treatment. RESULTS: During the study period, 2,512,635 out of 2,648,298 infants (94.88%) were screened within 72 h of birth. Of these, 71,041 (2.83%) tested positive for screening, and 23,150 (32.59%) of those positive were diagnosed with CHD. From 2018 to 2023, there was approximately a twofold decrease in the infant mortality rate (IMR) due to CHD, from 0.37‰ to 0.14‰ (APC= -17.33, P < 0.001), and a reduction in the under-five mortality rate (U5MR) due to CHD, from 0.45‰ to 0.17‰ (APC= -16.79, P < 0.001). CONCLUSIONS AND RELEVANCE: The current study provides encouraging evidence that the screening program has effectively advanced the diagnosis of CHD in children and reduced infant mortality, thereby supporting health rights and benefiting children with CHD throughout the province. Furthermore, our analysis demonstrates that the newborn CHD screening program has been effectively implemented across Jiangsu province's healthcare systems.
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Lü et al. (2025) conducted an observational in Congenital heart disease (n=2,512,635). Newborn congenital heart disease screening program (dual-index method) vs. Pre-program period (2018) was evaluated on Infant mortality rate (IMR) due to CHD (APC -17.33, p=<0.001). The implementation of a newborn congenital heart disease screening program was associated with a significant decrease in the infant mortality rate due to CHD from 0.37‰ to 0.14‰.
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