Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Prevention of nephrocalcinosis
研究概览
简要总结
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Days 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants < 32 weeks gestation age and < 1500 g birth weight
排除标准
- •Cardial, renal or gastrointestinal malformations
- •Chronic renal failure
- •Therapy with vitamin B6
- •High dose treatment with furosemide or dexamethasone
- •Addison's disease
- •Severe metabolic alkalosis
- •Worse clinical condition of preterm infant, which makes oral feeding impossible
- •Participation in other studies
结局指标
主要结局
Prevention of nephrocalcinosis
时间窗: First eight weeks of life
Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
次要结局
- Increase in urinary citrate excretion(First eight weeks of life)
研究者
Prof. Dr. B. Hoppe
Head, Division of Pediatric Nephrology
University of Cologne