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 sitesMay 10, 2012

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundació Clínic per a la Recerca Biomèdica

•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

•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.