Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature

Juan A. Arnaiz74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Nephrocalcinosis

Interventions

Potassium CitrateDRUG

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 or unacceptable toxicity develops.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 7 DaysMax age: 16 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: 1. Premature infants of both sexes born at the Hospital Clinic of Barcelona. 2. Corrected gestational age below 32 weeks and lower birth weight 1500gr. 3. Survivors at 7 days old. 4. Clinically stable, in the opinion of the investigator, at the time of inclusion. 5. 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 Exclusion Criteria: 1. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis. 2. 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) 3. Treatment with furosemide or dexamethasone 4. Addison's disease. 5. Persistent severe metabolic alkalosis. 6. Impossibility of oral feeding.

Locations (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

incidence of nephrocalcinosis in extremely preterm infants

Time frame: 38-40 weeks of corrected gestational age

Secondary Outcomes

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

Time frame: 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

To determine whether administration of potassium citrate in extreme premature infants improves the levels of phosphorus, potassium, sodium, citrate, creatinine, oxalate, and ratio citrate / calcium and ph in urine in each treatment arm at the 38-40 weeks.

Time frame: 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.

Determine whether the administration of potassium citrate in extreme premature neonates improves the plasma levels of sodium, potassium, creatinine, calcium, and blood ph value in each of the branches of treatment at 38-40 weeks.

Time frame: 38-40 weeks of corrected gestational age

To determine the incidence of adverse events and serious adverse events related to study treatment.

Central Contacts

Judit Pich Martínez, Pharmacist

CONTACT

0034 93 227 54 00 jpich@clinic.ub.es

Francisco Botet Mussons, MD

CONTACT

fbotet@clinic.ub.es

Data from ClinicalTrials.gov

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