NCT00593801

Erythropoietin Treatment in Extremely Low Birth Weight Infants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Low Birth Weight
• Anemia

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 1998-05-01
• Primary completion: 1999-06-01
• Completion: 1999-06-01
• First posted: 2008-01-15
• Last updated: 2008-01-15

Locations

1 site across 1 country: Germany