The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants

• Status: Completed
• Trial end date: 2000-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of <1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Infants with a birth weight of 4010-1250g, <32 weeks' gestation, and 24-96 hours old at the time of study entry

• Likely to survive >72 hours

• Informed consent from a parent or guardian.

Exclusion Criteria:

• Major congenital anomaly

• A positive direct antiglobulin test

• Evidence of coagulopathy

• Clinical seizures

• Systolic blood pressure >100 mm Hg (in the absence of pressor support)

• Absolute neutrophil count (ANC) of <=500/micro-L