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临床试验/NCT01176162
NCT01176162已完成不适用

PREMALDO : Aldosterone Resistance in Preterm Infants : Assessment by a Non Invasive Measurement of Urinary Aldosterone

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
urinary aldosterone

研究概览

简要总结

In the neonatal period, the human kidney is characterized by a functional immaturity responsible for an impaired ability to regulate water and sodium homeostasis, which is exacerbated by prematurity. This altered sodium handling could be related to a partial renal aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The investigators have analyzed MR expression throughout human and mouse renal development, and the investigators found a weak MR expression at birth. The investigators have conducted a pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance. This study also highlighted that urinary aldosterone is the best index to accurately assess aldosterone sensitivity at birth.

详细描述

Principal objective:

To assess aldosterone resistance at birth by a non invasive measurement of urinary aldosterone, in order to evaluate its intensity as a function of gestational age. Determination of normal values of urinary aldosterone concentration in each group.

Secondary objectives:

Comparison of plasma and urinary electrolytes concentrations with hormonal measurements and clinical parameters. Evolution of these biological parameters throughout the first year of life, depending on gestational age at birth.

Methodology : multicentric study, open study Two hundred-forty newborns will be included in order to constitute 4 groups of 60 children, classified according to their gestational age: < 28 GW, 28 - < 33 GW, 33- < 37 GW, > 37 GW.

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
24 Weeks 至 41 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

urinary aldosterone

时间窗: during the first year of life

Determination of normal values of urinary aldosterone concentration in each group (24 first hours, day three, and at 1 and 3 months)

次要结局

  • hormonal measurements(first year of life)
  • clinical parameters(first year of life)
  • plasma electrolytes concentrations(first year of life)
  • urinary electrolytes concentrations(first year of life)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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