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

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Citric Acid; Potassium Citrate

Criteria

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.