Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalc… (NCT01756547) | Clinical Trial Compass
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 range
7 Days – 16 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
incidence of nephrocalcinosis in extremely preterm infants
Timeframe: 38-40 weeks of corrected gestational age