Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature. Study PRENECA
- Conditions
- incidence of nephrocalcinosis in extremely preterm infantsMedDRA version: 14.1Level: PTClassification code 10029146Term: NephrocalcinosisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2012-000298-22-ES
- Lead Sponsor
- Fundació Clínic per a la Recerca Biomèdica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
a. Premature infants of both sexes born at the Hospital Clínic of Barcelona.
b. Corrected gestational age below 32 weeks and lower birth weight 1500gr.
c. Survivors at 7 days old.
e. Clinically stable, in the opinion of the investigator, at the time of inclusion.
f. 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 74
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
b. 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)
c. Treatment with furosemide or dexamethasone
d. Addison's disease.
e. Persistent severe metabolic alkalosis.
f. Impossibility of oral feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method