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临床试验/NCT03957863
NCT03957863Unknown不适用

Study of Erythropoietin in Newborns and Children

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
EPO concentration UI/L

研究概览

简要总结

Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney.

Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml.

In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities.

The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.

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
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study

排除标准

  • child treated with recombinant erythropoietin

结局指标

主要结局

EPO concentration UI/L

时间窗: Baseline

Electrophoretic profile of EPO

时间窗: Baseline

It is an indicator of glycosylation differences (more complex forms including sialic acids are more acidic, less complex forms are more basic)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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