A multicentre observational study on neonates exposed to SARS-CoV-2 in China: the Neo-SARS-CoV-2 Study protocol

Tiantian Xiao, Shiwen Xia, Linkong Zeng, Guang Lin, Qiufen Wei, Wei Zhou, Deyi Zhuang, Xiao Chen, Bin Yi, Long Li, Hongying Mi, Zhaoqing Yin, Xiuyong Cheng, Laishuan Wang, Xiaojing Hu, Wenhao Zhou, Tiantian Xiao, Shiwen Xia, Linkong Zeng, Guang Lin, Qiufen Wei, Wei Zhou, Deyi Zhuang, Xiao Chen, Bin Yi, Long Li, Hongying Mi, Zhaoqing Yin, Xiuyong Cheng, Laishuan Wang, Xiaojing Hu, Wenhao Zhou

Abstract

Introduction: An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred in Wuhan, China starting in December 2019. Yet the clinical features and long-term outcomes of neonates with SARS-CoV-2 exposure are lacking. The purpose of this study is to describe the clinical course and prognosis of the neonates exposed to SARS-CoV-2.

Methods and analysis: This is a multicentre observational study conducted at the designated children and maternal and child hospitals in the mainland of China. Neonates exposed to SARS-CoV-2 infection will be recruited. The data to be collected via case report forms include demographic details, clinical features, laboratory and imaging results, as well as outcomes. Primary outcomes are the mortality of neonates with COVID-19 and SARS-CoV-2 infection of neonates born to mothers with COVID-19. Secondary outcomes are the birth weight, premature delivery and neurological development of neonates exposed to SARS-CoV-2. The neurological development is assessed by the Chinese standardised Denver Developmental Screening Test at the corrected age of 6 months.

Ethics and dissemination: This study has been approved by the Children's Hospital of Fudan University ethics committee (No. (2020)31). The study findings will be disseminated in peer-reviewed journals and presented at national and international conferences in order to improve the understanding of the clinical course among neonates exposed to SARS-CoV-2 and to provide evidence-based treatment and prevention strategies for this group.

Trial registration number: NCT04279899.

Keywords: infectious diseases; neonatal intensive & critical care; perinatology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Protocol and follow-up of neonates exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Regarding the enrolment time point, the neonates born to mothers with COVID-19 are enrolled on the day of birth and the neonates with COVID-19 are enrolled on the day of admission. DDST, Denver Developmental Screening Test.

References

    1. Chen Y, Liu Q, Guo D. Emerging coronaviruses: genome structure, replication, and pathogenesis. J Med Virol 2020;92:418–23. 10.1002/jmv.25681
    1. Wrapp D, Wang N, Corbett KS, et al. . Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science 2020;367:1260–3. 10.1126/science.abb2507
    1. Chan JF-W, Yuan S, Kok K-H, et al. . A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020;395:514–23. 10.1016/S0140-6736(20)30154-9
    1. Xu Y, Li X, Zhu B, et al. . Characteristics of pediatric SARS-CoV-2 infection and potential evidence for persistent fecal viral shedding. Nat Med 2020;26:502–5. 10.1038/s41591-020-0817-4
    1. Zhu H, Wang L, Fang C, et al. . Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Transl Pediatr 2020;9:51–60. 10.21037/tp.2020.02.06
    1. Chen H, Guo J, Wang C, et al. . Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet 2020;395:809–15. 10.1016/S0140-6736(20)30360-3
    1. Li AM, Ng PC. Severe acute respiratory syndrome (SARS) in neonates and children. Arch Dis Child Fetal Neonatal Ed 2005;90:F461–5. 10.1136/adc.2005.075309
    1. Zheng QL, Duan T, Jin LP. Single-cell RNA expression profiling of ACE2 and Axl in the human maternal–Fetal interface. Available:
    1. Huang C, Wang Y, Li X, et al. . Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497–506. 10.1016/S0140-6736(20)30183-5
    1. Guan W-J, Ni Z-Y, Hu Y, et al. . Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:1708–20. 10.1056/NEJMoa2002032
    1. Liu W, Zhang Q, Chen J, et al. . Detection of Covid-19 in children in early January 2020 in Wuhan, China. N Engl J Med 2020;382:1370–1. 10.1056/NEJMc2003717
    1. Wei M, Yuan J, Liu Y, et al. . Novel coronavirus infection in hospitalized infants under 1 year of age in China. JAMA 2020. 10.1001/jama.2020.2131. [Epub ahead of print: 14 Feb 2020].
    1. Zeng LK, Tao XW, Yuan WH, et al. . [First case of neonate infected with novel coronavirus pneumonia in China]. Zhonghua Er Ke Za Zhi 2020;58:E009. 10.3760/cma.j.issn.0578-1310.2020.0009
    1. Musilova I, Andrys C, Drahosova M, et al. . Late preterm prelabor rupture of fetal membranes: fetal inflammatory response and neonatal outcome. Pediatr Res 2018;83:630–7. 10.1038/pr.2017.300
    1. Francis F, Bhat V, Mondal N, et al. . Fetal inflammatory response syndrome (FIRS) and outcome of preterm neonates - a prospective analytical study. J Matern Fetal Neonatal Med 2019;32:488–92. 10.1080/14767058.2017.1384458
    1. Desforges M, Le Coupanec A, Dubeau P, et al. . Human coronaviruses and other respiratory viruses: underestimated opportunistic pathogens of the central nervous system? Viruses 2019;12:14. 10.3390/v12010014
    1. Yeh EA, Collins A, Cohen ME, et al. . Detection of coronavirus in the central nervous system of a child with acute disseminated encephalomyelitis. Pediatrics 2004;113:e73–6. 10.1542/peds.113.1.e73
    1. Wong SF, Chow KM, Leung TN, et al. . Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol 2004;191:292–7. 10.1016/j.ajog.2003.11.019
    1. Alfaraj SH, Al-Tawfiq JA, Memish ZA. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection during pregnancy: Report of two cases & review of the literature. J Microbiol Immunol Infect 2019;52:501–3. 10.1016/j.jmii.2018.04.005
    1. Shek CC, Ng PC, Fung GPG, et al. . Infants born to mothers with severe acute respiratory syndrome. Pediatrics 2003;112:e254. 10.1542/peds.112.4.e254
    1. Rasmussen SA, Olney RS, Holmes LB, et al. . Guidelines for case classification for the National birth defects prevention study. Birth Defects Res A Clin Mol Teratol 2003;67:193–201. 10.1002/bdra.10012
    1. Wang L, Shi Y, Xiao T, et al. . Chinese expert consensus on the perinatal and neonatal management for the prevention and control of the 2019 novel coronavirus infection (first edition). Ann Transl Med 2020;8:47. 10.21037/atm.2020.02.20
    1. China NHC New coronavirus pneumonia prevention and control protocol. 5 edn National Health Commission of the People’s Republic of China, 2020.
    1. Xie Z-H, Bo S-Y, Zhang X-T, et al. . Sampling survey on intellectual disability in 0 approximately 6-year-old children in China. J Intellect Disabil Res 2008;52:1029–38. 10.1111/j.1365-2788.2008.01048.x
    1. Committee on Children With Disabilities Developmental surveillance and screening of infants and young children. Pediatrics 2001;108:192–5. 10.1542/peds.108.1.192
    1. Zeng L, Xia S, Yuan W, et al. . Neonatal early-onset infection with SARS-CoV-2 in 33 neonates born to mothers with COVID-19 in Wuhan, China. JAMA Pediatr 2020;174:722. 10.1001/jamapediatrics.2020.0878

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