Erythropoietin Treatment in Extremely Low Birth Weight Infants
- Registration Number
- NCT00593801
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- Extremely low birth weight infants
- Cyanotic heart disease
- Major congenital malformation requiring surgery
- Gestational age > 30 weeks
- Administration of an investigational drug during pregnancy
- Lack of parental consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2: late rhEPO epoetin beta late EPO treatment from the fourth week for 6 weeks 1: early rhEPO epoetin beta early rhEPO treatment from the first week until 9 weeks
- Primary Outcome Measures
Name Time Method transfusion need 9 weeks
- Secondary Outcome Measures
Name Time Method concentrations of trace elements and antioxidant enzymes in the blood 9 weeks
Trial Locations
- Locations (1)
Dept of Neonatolgy Charité University Medicine Berlin
🇩🇪Berlin, Germany