Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants

University of Cologne80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Nephrocalcinosis

Interventions

Eligibility

Sex: ALLMin age: 5 DaysMax age: 8 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants \< 32 weeks gestation age and \< 1500 g birth weight Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Prevention of nephrocalcinosis

Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.

Time frame: First eight weeks of life

Secondary Outcomes

Increase in urinary citrate excretion

Increase in urinary citrate excretion under prophylactic treatment