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临床试验/NCT05379452
NCT05379452终止不适用

Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2022年3月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
终止
入组人数
236
试验地点
1
主要终点
The death of newborns
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 28 Days（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Neonates born to mothers with SARS-CoV-2 infections.

排除标准

  • •Parents who rejected to participate in this study.

结局指标

主要结局

The death of newborns

时间窗: The date of discharge，an average of 4 weeks after the admission

次要结局

  • The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections(Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year)
  • The malformation rate of neonates born to mothers with SARS-CoV-2 infections(Birth)
  • The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections(Birth)
  • The development delay rate of neonates born to mothers with SARS-CoV-2 infections(within 1 year after the admission)
  • The brain injury rate of neonates born to mothers with SARS-CoV-2 infections(within 7days after the admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Outcomes of Neonates Born to Mothers With SARS-CoV-2... | 临床试验