Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
- Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ] [ Designated as safety issue: No ]Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
- Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ] [ Designated as safety issue: No ]Increase in urinary citrate excretion under prophylactic treatment
|Study Start Date:||November 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Drug: Alkaline citrate
|Prof. Dr. Bernd Hoppe|
|Cologne, Germany, D-50924|
|Principal Investigator:||Bernd Hoppe, Prof. Dr.||University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany|