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临床试验/NCT04921241
NCT04921241已完成不适用

In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Aortic pulse-wave velocity

研究概览

简要总结

Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
9 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)

排除标准

  • Child with any history of documented COVID-19
  • Mother who received the COVID-19 vaccine during pregnancy with her child
  • Significant chronic illness in mother or child judged by the investigator to represent a contraindication to study participation

结局指标

主要结局

Aortic pulse-wave velocity

时间窗: Baseline

次要结局

  • Beta index of aortic stiffness using echocardiogram(Baseline)
  • Urinary angiotensin peptide levels(Baseline)
  • Urinary angiotensin converting enzyme (ACE) levels(Baseline)
  • Aortic intima-media thickness using echocardiogram(Baseline)
  • Left ventricular dimensions(Baseline)
  • Left ventricular mass(Baseline)
  • Skinfold thicknesses (subscapular, triceps)(Baseline)
  • Weight-for-length z-score(Baseline)
  • Systolic and diastolic blood pressure(Baseline)

研究者

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

Lindsay Fourman, MD

Assistant Professor of Medicine

Massachusetts General Hospital

研究点 (1)

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