Erythropoietin Treatment in Extremely Low Birth Weight Infants (EPO)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity|
- transfusion need [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
- concentrations of trace elements and antioxidant enzymes in the blood [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 1998|
|Study Completion Date:||June 1999|
|Primary Completion Date:||June 1999 (Final data collection date for primary outcome measure)|
Active Comparator: 2: late rhEPO
late EPO treatment from the fourth week for 6 weeks
Drug: epoetin beta
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
No Intervention: 3: no EPO
control group, no EPO treatment
Active Comparator: 1: early rhEPO
early rhEPO treatment from the first week until 9 weeks
Drug: epoetin beta
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
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.
|Dept of Neonatolgy Charité University Medicine Berlin|
|Berlin, Germany, 13353|
|Principal Investigator:||Michael Obladen, Prof.Dr.||Charité Berlin, University Medicine|