UnknownPhase 3

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

Spain74 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range7 Days – 16 Weeks

SexALL

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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.

What they're measuring

incidence of nephrocalcinosis in extremely preterm infants

Timeframe: 38-40 weeks of corrected gestational age

Trial details

NCT IDNCT01756547

SponsorJuan A. Arnaiz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Contact for this trial

Judit Pich Martínez, Pharmacist

0034 93 227 54 00 jpich@clinic.ub.es

View on ClinicalTrials.gov More Nephrocalcinosis trials