incidence of nephrocalcinosis in extremely preterm infants MedDRA version: 14.1 Level: PT Classification code 10029146 Term: Nephrocalcinosis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Potassium Citrate
Product Code: NA
Pharmaceutical Form: Oral solution
CAS Number: 06/05/6100
Other descriptive name: POTASSIUM CITRATE
Concentration unit: mEq/kg milliequivalent(s)/kilog
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether potassium citrate administration in extremely premature neonates (less than 1500g birth weight and less than 32 weeks gestational age) reduces the incidence of nephrocalcinosis at 38-40 weeks of corrected age.;Secondary Objective: 1. 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. 2. 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. 3. 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. 4. To determine the incidence of adverse events and serious adverse events related to study treatment.;Primary end point(s): Proportion of infants with nephrocalcinosis assessed ecographically at 38-40 weeks of corrected gestational age.;Timepoint(s) of evaluation of this end point: at 38-40 weeks of corrected gestational age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change from baseline in the levels of calcium and calcium / creatinine ratio in urine between both arms at 38-40 weeks. ? Change from baseline in the levels of phosphorus, potassium, sodium citrate, creatinine, oxalates and the ratio citrate / calcium and urine pH value between both arms at 38-40 weeks. ? Change from baseline in plasma levels of sodium, potassium, creatinine, calcium, and blood pH value between both arms at 38-40 weeks. ? Incidence of clinical and laboratory adverse events between both arms at 38-40 weeks. ? Proportion of infants with serious adverse events related to study medication at 38-40 weeks.;Timepoint(s) of evaluation of this end point: at 38-40 weeks of corrected gestational age | — |
Countries
Spain
Contacts
Public ContactJudit Pich
Clinical trials unit (Hospital Clínic)
Outcome results
None listed