Abstract 1268 Clinical Trials in Perinatal Neonatal Medicine Platform, Tuesday, 5/4

OBJECTIVE: Preterm infants receive multiple packed red blood cell transfusions (TX) during their hospitalization. This study tested whether Epo therapy and iron supplementation started by 4 days of age and continued through the 35th week post-conception could a) decrease the number of TX (infants ≤1000 grams; Trial 1), and b) increase the percentage of infants not requiring TX (infants 1001-1250 grams; Trial 2). METHODS: Preterm infants ≤1250 grams birth weight were randomized to receive Epo (400 units/kg 3x/week) or placebo/control. Doses were administered intravenously (IV) or subcutaneously (SC). The placebo/control group received saline IV, but sham dosing instead of SC administration. All infants received supplemental IV iron (Epo 5 mg/kg/week; placebo 1 mg/kg/week), or enteral iron (6 mg/kg/day for both groups). Phlebotomy losses, TX, and TX volumes were recorded, and TX were administered according to protocol. CBCs and reticulocyte counts (retics) were measured weekly, and serum ferritins were measured every 4 weeks. RESULTS: A total of 290 infants were enrolled (172 in Trial 1, 118 in Trial 2). Phlebotomy losses were similar between groups in both trials. Trial 1 measures are shown below: (Table) Despite signs of active erythropoiesis and higher hematocrits (Hcts), the Epo group in Trial 1 (n=87) received a similar number of TX/patient, but a lower volume of transfused PRBCs/patient than controls (n=85) (Epo 4.3±3.7 TX and 61±45 mL; control 5.2±4.3 TX and 85±61 mL, p<0.01 for volume transfused). For Trial 2, 64% of the Epo group (n=59) and 53% of controls (n=59) received no TX. Both groups received a similar number and volume of TX/patient (Epo 0.9±1.5, 42±28 mL; control 1.0±1.6, 43±26 mL). Hcts, retics, and ferritins showed similar trends to values seen in Trial 1. No adverse effects of Epo or supplemental iron were noted, and the incidence of severe intraventricular hemorrhage, patent ductus arteriosus, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, late onset infection, length of hospital stay, and mortality was similar in the two groups. CONCLUSION: The combination of early Epo and iron appears to be safe, and stimulates erythropoiesis in preterm infants ≤1250 grams, but does not reduce TX requirements.

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