NCT04279899

The Investigation of the Neonates With or With Risk of COVID-19

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Infection
• Perinatal Problems
• Infectious Disease

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2020-02-21
• Last updated: 2023-12-28

Locations

2 sites across 1 country: China