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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Juan A. Arnaiz

Current Primary Outcome: incidence of nephrocalcinosis in extremely preterm infants [ Time Frame: 38-40 weeks of corrected gestational age ]

incidence of nephrocalcinosis in extremely preterm infants


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 38-40 weeks of corrected gestational age ]
    To determine the incidence of adverse events and serious adverse events related to study treatment.


Original Secondary Outcome: Same as current

Information By: Hospital Clinic of Barcelona

Dates:
Date Received: December 20, 2012
Date Started: January 2013
Date Completion: January 2014
Last Updated: December 26, 2012
Last Verified: December 2012