Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- incidence of nephrocalcinosis in extremely preterm infants
研究概览
简要总结
Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Days 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants of both sexes born at the Hospital Clinic of Barcelona.
- •Corrected gestational age below 32 weeks and lower birth weight 1500gr.
- •Survivors at 7 days old.
- •Clinically stable, in the opinion of the investigator, at the time of inclusion.
- •That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails
排除标准
- •Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
- •Chronic renal failure (serum creatinine> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis <0.5 mL / kg / hour after the first day of life)
- •Treatment with furosemide or dexamethasone
- •Addison's disease.
- •Persistent severe metabolic alkalosis.
- •Impossibility of oral feeding.
研究组 & 干预措施
Potassium citrate
Potassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age.
干预措施: Potassium Citrate (Drug)
Placebo
Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of nephrocalcinosis in extremely preterm infants
时间窗: 38-40 weeks of corrected gestational age
incidence of nephrocalcinosis in extremely preterm infants
次要结局
- To determine the incidence of adverse events and serious adverse events related to study treatment.(38-40 weeks of corrected gestational age)
- Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks(38-40 weeks of corrected gestational age)
- To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value(38-40 weeks of corrected gestational age)
- Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.(38-40 weeks of corrected gestational age)
研究者
Juan A. Arnaiz
Project manager Clinical Trials Unit
Hospital Clinic of Barcelona