The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants
Condition: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Anemia, Neonatal
MeSH terms: Anemia, Neonatal; Birth Weight
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Critically ill preterm infants experience in the first 1-2 weeks after birth daily blood
      losses that may equal 5-10% of their total blood volume. Such losses and associated anemia
      typically result in multiple erythrocyte transfusions. This iatrogenic anemia commonly is
      followed by the anemia of prematurity, prompting additional transfusions.

      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 (Trial 1), we tested
      whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions
      received. For infants 1,001-1,250g birth weight (Trial 2), we tested whether early
      erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received
      any transfusions.

      Therapy was initiated by day of life 4 and continued through the 35th postmenstrual week.
      Infants were randomized to receive either Epo and iron therapy or a sham procedure. Treated
      infants received 400 U/kg Epo 3 times weekly and a weekly intravenous infusion of 5 mg/kg
      iron dextran until they had an enteral intake of 60 mL/kg/d. Infants in the placebo/control
      group received sham subcutaneous injections when intravenous access was not available.
      Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were
      measured monthly.

      Transfusions were administered according to protocol. Infants did not receive a transfusion
      solely to replace blood lost through phlebotomy. Infants who met transfusion criteria
      received a transfusion of 15 mL/kg packed red blood cells (PRBC) for a hematocrit of >25% or
      20 mL/kg PRBC for a hematocrit of <=25%. Blood losses and transfusion data were recorded.

      Trial 2 was terminated after enrollment of 118 infants after the Data and Safety Monitoring
      Committee reviewed the final results of Trial 1 and preliminary results of Trial 2. On the
      basis of these data, the Committee concluded that it was statistically unlikely that Trial 2
      would demonstrate a significant decrease in the percentage of infants who would receive a
      transfusion during the study.
    

Intervention name(s): Erythropoietin; Sham Comparator
Intervention type(s): Drug; Other
Intervention description(s): Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.; Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
Other intervention name(s): Human recombinant erythropoietin
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Erythrocyte transfusions; Erythropoietin (Epo); Blood loss; Phlebotomy