PRENECAL: Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Potassium citrate 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
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.
|
| Placebo Comparator: Placebo Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day. |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- incidence of nephrocalcinosis in extremely preterm infants [38-40 weeks of corrected gestational age]
incidence of nephrocalcinosis in extremely preterm infants
Secondary Outcome Measures
- 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]
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
- To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value [38-40 weeks of corrected gestational age]
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.
- Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value. [38-40 weeks of corrected gestational age]
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.
- To determine the incidence of adverse events and serious adverse events related to study treatment. [38-40 weeks of corrected gestational age]
To determine the incidence of adverse events and serious adverse events related to study treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Premature infants of both sexes born at the Hospital Clinic of Barcelona.
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Corrected gestational age below 32 weeks and lower birth weight 1500gr.
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Survivors at 7 days old.
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Clinically stable, in the opinion of the investigator, at the time of inclusion.
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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:
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Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
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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)
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Treatment with furosemide or dexamethasone
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Addison's disease.
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Persistent severe metabolic alkalosis.
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Impossibility of oral feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Juan A. Arnaiz
Investigators
- Principal Investigator: Francisco Botet Mussons, MD, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRENECAL