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临床试验/NCT04470739
NCT04470739Unknown不适用

Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Cardiothymic index

研究概览

简要总结

COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

详细描述

COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 7 Hours(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Infants born to COVID-19 positive or negative mothers
  • •Accepted to participate with an informed consent
  • •Infants who required to get chest X-ray within the first 6 hours

排除标准

  • •Infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection
  • •Lack of an informed consent
  • •Infants who did not require to get chest X-ray within the first 6 hours

研究组 & 干预措施

Infants born to COVID-19 positive mothers

Active Comparator

Infants, born to COVID-19 positive mothers, will be evaluated for cardiothymic index in their first chest X-ray.

干预措施: chest x-ray (Diagnostic Test)

Infants born to COVID-19 negative mothers

No Intervention

Infants, born to COVID-19 negative mothers, will be evaluated for cardiothymic index in their first chest X-ray.

结局指标

主要结局

Cardiothymic index

时间窗: 4 months

Cardiothymic index will be measured by using the thymic shadow divided by largest diameter of mediastinum in the chest X-ray of those infants.

次要结局

  • Immune profile(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Yilmaz Semerci

Neonatologist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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