A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The SARS-CoV-2 infection of neonates born to mothers with COVID-19
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The neonates with COVID-19,or neonates born by infected mothers
排除标准
- •The neonates with major anomalies
结局指标
主要结局
The SARS-CoV-2 infection of neonates born to mothers with COVID-19
时间窗: within 7days after the admission
Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.
The death of newborns with COVID-19
时间窗: The date of discharge，an average of 4 weeks after the admission
次要结局
- The small for gestational age newborns in the neonates born to mothers with COVID-19(at birth)
- The preterm delivery of neonates born to mothers with COVID-19(at birth)
- The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19(Infants ( ≥35 weeks）are at 6 months after birth;Infants（< 35weeks） are at a corrected age of 6 months.)
- The disease severity of neonates with COVID-19(through study completion, estimated an average of 2 weeks)