跳至主要内容
临床试验/NCT04860583
NCT04860583已完成不适用

Nephrocalcinosis in Very Low Birth Weight Infants: an Observational Study

Hospices Civils de Lyon0 个研究点目标入组 265 人开始时间: 2012年1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
265
主要终点
Prevalence of nephrocalcinosis

研究概览

简要总结

Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis. Other identified risk factors are extreme prematurity and intrauterine growth restriction.

The incidence of nephrocalcinosis in very premature infants is unclear, ranging from 7 to 64%. Most studies are observational and only few case-control studies can properly analyse the risk factors for nephrocalcinosis in significant populations that include only preterm infants.

This nephrocalcinosis of prematurity regresses spontaneously in more than half of the cases, but has been associated with a risk of long-term complications: impaired renal function, high blood pressure, etc. This is an aggravating factor in the context of prematurity, which has been associated with an increased risk of renal impairment and hypertension in childhood and adulthood.

For all these reasons, nutritional intakes and therapeutics are monitored very closely and a renal ultrasound is routinely performed at discharge at 35 weeks of corrected gestational age in all children who are born at a gestational age ≤ 32 weeks and/or birth weight ≤ 1500 g.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Newborns with a gestational age <= 32 weeks and/or birthweight <=1500g

排除标准

  • Newborns with kidney malformation

结局指标

主要结局

Prevalence of nephrocalcinosis

时间窗: At week 35 of corrected gestational age

Presence/absence of nephrocalcinosis will be checked by ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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