Official Title
A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China
Brief Summary

Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.

Detailed Description

Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and
is contagious to the general population, all the suspected or confirmed newborns will be
admitted to the neonatal departments in designated hospitals of China. In this study, the
diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National
Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will
be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic
fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical
information questionnaires are classified into maternal and neonatal version, which include
demographic details, epidemical history, clinical manifestations, tests collected time and
results, imaging performed time and results and therapeutic data. Two researchers
independently checked and recorded the data to ensure the accuracy of the data.

Recruiting
Neonatal Infection
Perinatal Problems
Infectious Disease
Eligibility Criteria

Inclusion Criteria:

- The neonates with COVID-19,or neonates born by infected mothers

Exclusion Criteria:

- The neonates with major anomalies

Eligibility Gender
All
Eligibility Age
Minimum: 0 Days ~ Maximum: 28 Days
Countries
China
Locations

Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China

Children Hospital of Fudan University
Shanghai, Shanghai, China

Children's Hospital of Fudan University
NCT Number
MeSH Terms
Communicable Diseases
Infections