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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nephrocalcinosis

Intervention / Treatment
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* Drug: Potassium Citrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 16 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potassium citrate<br>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. | Drug: Potassium Citrate<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of nephrocalcinosis in extremely preterm infants | incidence of nephrocalcinosis in extremely preterm infants | 38-40 weeks of corrected gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 38-40 weeks of corrected gestational age | 
| To determine the incidence of adverse events and serious adverse events related to study treatment. | To determine the incidence of adverse events and serious adverse events related to study treatment. | 38-40 weeks of corrected gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephrocalcinosis, Extreme premature