Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment. The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Study population: 219 patient randomized into 3 groups
Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%. The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
219
250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day
250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
Dept of Neonatolgy Charité University Medicine Berlin
Berlin, State of Berlin, Germany
transfusion need
Time frame: 9 weeks
concentrations of trace elements and antioxidant enzymes in the blood
Time frame: 9 weeks
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