Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
- Conditions
- Nephrocalcinosis
- Registration Number
- NCT00249951
- Lead Sponsor
- University of Cologne
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Preterm infants < 32 weeks gestation age and < 1500 g birth weight
- Cardial, renal or gastrointestinal malformations
- Chronic renal failure
- Therapy with vitamin B6
- High dose treatment with furosemide or dexamethasone
- Addison's disease
- Severe metabolic alkalosis
- Worse clinical condition of preterm infant, which makes oral feeding impossible
- Participation in other studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Prevention of nephrocalcinosis First eight weeks of life Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
- Secondary Outcome Measures
Name Time Method Increase in urinary citrate excretion First eight weeks of life Increase in urinary citrate excretion under prophylactic treatment
Trial Locations
- Locations (1)
Prof. Dr. Bernd Hoppe
🇩🇪Cologne, Germany