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. Study PRENECAL - PRENECA

Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2012年5月10日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•a. Premature infants of both sexes born at the Hospital Clínic of Barcelona.
•b. Corrected gestational age below 32 weeks and lower birth weight 1500gr.
•c. Survivors at 7 days old.
•e. Clinically stable, in the opinion of the investigator, at the time of inclusion.
•f. 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 74
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
•b. 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)
•c. Treatment with furosemide or dexamethasone
•d. Addison's disease.
•e. Persistent severe metabolic alkalosis.
•f. Impossibility of oral feeding.

发起方

Fundació Clínic per a la Recerca Biomèdica