E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
incidence of nephrocalcinosis in extremely preterm infants |
incidencia de nefrocalcinosis en prematuros extremos |
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E.1.1.1 | Medical condition in easily understood language |
incidence of nephrocalcinosis in extremely preterm infants |
incidencia de nefrocalcinosis en prematuros extremos |
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E.1.1.2 | Therapeutic area | Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029146 |
E.1.2 | Term | Nephrocalcinosis |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether potassium citrate administration in extremely premature neonates (less than 1500g birth weight and less than 32 weeks gestational age) reduces the incidence of nephrocalcinosis at 38-40 weeks of corrected age. |
Determinar si la administración de citrato potásico en prematuros extremos (de menos de 1500g de peso al nacimiento y menos de 32 semanas de edad gestacional) disminuye la incidencia de nefrocalcinosis a las 38-40 semanas de edad corregida. |
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E.2.2 | Secondary objectives of the trial |
1. 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. 2. 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. 3. 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. 4. To determine the incidence of adverse events and serious adverse events related to study treatment. |
1. Determinar si la administración de citrato potásico en prematuros extremos disminuye los niveles de calcio y del cociente calcio/creatinina en orina en cada una de las ramas de tratamiento a las 38-40 semanas. 2. Determinar si la administración de citrato potásico en prematuros extremos mejora los niveles de fósforo, potasio, sodio, citrato, creatinina, oxalatos y del cociente citrato/calcio y valor de pH en orina en cada una de las ramas de tratamiento a las 38-40 semanas. 3. Determinar si la administración de citrato potásico en prematuros extremos mejora los niveles plasmáticos de sodio, potasio, creatinina, calcio y valor de pH en sangre en cada una de las ramas de tratamiento a las 38-40 semanas. 4. Determinar la incidencia de acontecimientos adversos y acontecimientos adversos graves relacionados con el tratamiento en estudio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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 |
a. Prematuros de ambos sexos nacidos en el Hospital Clínic de Barcelona. b. Edad gestacional corregida inferior a las 32 semanas y peso al nacer inferior de 1500gr. c. Supervivientes a los 7 días de vida. e. Clínicamente estables, en opinión del investigador, en el momento de la inclusión. f. Que, adecuadamente informados, los padres y/o tutores legales otorguen su consentimiento por escrito para permitir la participación del neonato en el estudio y someterle a las pruebas y exploraciones que ello comporta |
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E.4 | Principal exclusion criteria |
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. |
a. Malformaciones renales, cardíacas o gastrointestinales de diagnóstico prenatal o postnatal. b. Insuficiencia renal crónica (creatinina plasmática >1,5 mg/dL o incremento de 0,3 mg/dL/día y/o oliguria definido como diuresis < 0,5 mL/kg/hora después del primer día de vida) c. En tratamiento con furosemida o dexametasona d. Enfermedad de Addison. e. Alcalosis metabólica grave persistente. f. Imposibilidad de alimentación oral. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of infants with nephrocalcinosis assessed ecographically at 38-40 weeks of corrected gestational age. |
Proporción de prematuros con nefrocalcinosis valorada ecográficamente a las 38-40 semanas de edad gestacional corregida. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at 38-40 weeks of corrected gestational age |
a las 38-40 semanas de edad gestacional corregida |
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E.5.2 | Secondary end point(s) |
? Change from baseline in the levels of calcium and calcium / creatinine ratio in urine between both arms at 38-40 weeks. ? Change from baseline in the levels of phosphorus, potassium, sodium citrate, creatinine, oxalates and the ratio citrate / calcium and urine pH value between both arms at 38-40 weeks. ? Change from baseline in plasma levels of sodium, potassium, creatinine, calcium, and blood pH value between both arms at 38-40 weeks. ? Incidence of clinical and laboratory adverse events between both arms at 38-40 weeks. ? Proportion of infants with serious adverse events related to study medication at 38-40 weeks. |
? Cambio respecto al basal de los niveles de calcio y del cociente calcio/creatinina en orina en cada una de las ramas de tratamiento a las 38-40 semanas. ? Cambio respecto al basal de los niveles de fósforo, potasio, sodio, citrato, creatinina, oxalatos y del cociente citrato/calcio y valor de pH en orina en cada una de las ramas de tratamiento a las 38-40 semanas. ? Cambio respecto al basal de los niveles plasmáticos de sodio, potasio, creatinina, calcio y valor de pH en sangre en cada una de las ramas de tratamiento a las 38-40 semanas. ? Incidencia de acontecimientos adversos clínicos y de laboratorio para cada una de las ramas de tratamiento a las 38-40 semanas. ? Proporción de prematuros con acontecimientos adversos graves relacionados con la medicación en estudio a las 38-40 semanas. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 38-40 weeks of corrected gestational age |
a las 38-40 semanas de edad gestacional corregida |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last patient in |
última visita de seguimiento del último paciente reclutado |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |