Erythropoietin Treatment in Extremely Low Birth Weight Infants — EPO  

Anemia Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Birth Weight
• Body Weight
• Infant, Low Birth Weight

• NCT number: NCT00593801
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: N/A
• Start date: May 1998
• Completion date: June 1999