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临床试验/NCT04382976
NCT04382976已完成不适用

The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants at the Neonatology Centre of Vilnius University Hospital Santaros Klinikos

Vilnius University1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2018年10月1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
171
试验地点
1
主要终点
The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation

研究概览

简要总结

The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.

详细描述

Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.

The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.

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
23 Weeks 至 31 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants of the gestational age of <32 weeks;
  • parental consent acquired.

排除标准

  • death before 28 days of age;
  • congenital defects;
  • no kidney ultrasound results;
  • no parental consent.

结局指标

主要结局

The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation

时间窗: 3 years

Kidney ultrasound results will divide preterm infants in the group with and without nephrocalcinosis (control).

次要结局

  • Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.(3 years)
  • To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.(6 and 12 months of corrected age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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