OBJECTIVES: The specific objectives of this study were (1) to assess the safety and efficacy of recombinant human erythropoietin (rhEPO) in reducing postnatal hemoglobin decline in premature infants of less than 33 weeks' gestation, and thus reducing the need for transfusion; and (2) to determine the optimal dosage of rhEPO. MATERIALS AND METHODS:Three groups of premature infants of less than 33 weeks' gestation were treated with rhEPO: group 1 (n = 10) received 300 U/kg per week; group 2 (n = 11), 600 U/kg per week; and group 3 (n = 10), 900 U/kg per week. These three groups were compared to a reference group of 20 infants of the same gestational age and birth weight. Treatment started on the 10th day of life and lasted 6 weeks. All infants were given oral iron and vitamin E supplements. RESULTS: Treated infants had significantly higher reticulocyte counts, and the effect was dose dependent (P = .009). Postnatal decline of hemoglobin and hematocrit was lessened in the treated groups; the percent of decrease of hemoglobin and hematocrit was significantly reduced in the treated infants at 35 days of age (P = .0025 and P = .0036, respectively). The need for blood transfusion was also reduced in the rhEPO-treated groups: 19% of treated vs 45% of reference infants received transfusions, and the treated infants received less blood. Serum iron and transferrin saturation percentage dropped significantly during the study and a dose-dependent relationship in treated infants was displayed, suggesting high iron consumption (P = .0008 and P = .006, respectively). No dose effect on hemoglobin level and the need for blood transfusion was found, possibly because of the higher degree of illness severity and iron consumption in groups 2 and 3. No side effects related to rhEPO therapy were observed. CONCLUSIONS: It is concluded that rhEPO therapy is safe in premature babies when given in the three dosages used in this study; in addition, it enhances erythropoiesis and reduces the need for blood transfusions. rhEPO therapy seems more efficient when given in higher dosages; however, illness severity and iron consumption represent major limiting factors. Controlled, randomized studies are warranted to confirm these data and to determine precise modalities and indications of rhEPO therapy in premature infants.
RCT Entities:
OBJECTIVES: The specific objectives of this study were (1) to assess the safety and efficacy of recombinant humanerythropoietin (rhEPO) in reducing postnatal hemoglobin decline in premature infants of less than 33 weeks' gestation, and thus reducing the need for transfusion; and (2) to determine the optimal dosage of rhEPO. MATERIALS AND METHODS: Three groups of premature infants of less than 33 weeks' gestation were treated with rhEPO: group 1 (n = 10) received 300 U/kg per week; group 2 (n = 11), 600 U/kg per week; and group 3 (n = 10), 900 U/kg per week. These three groups were compared to a reference group of 20 infants of the same gestational age and birth weight. Treatment started on the 10th day of life and lasted 6 weeks. All infants were given oral iron and vitamin E supplements. RESULTS: Treated infants had significantly higher reticulocyte counts, and the effect was dose dependent (P = .009). Postnatal decline of hemoglobin and hematocrit was lessened in the treated groups; the percent of decrease of hemoglobin and hematocrit was significantly reduced in the treated infants at 35 days of age (P = .0025 and P = .0036, respectively). The need for blood transfusion was also reduced in the rhEPO-treated groups: 19% of treated vs 45% of reference infants received transfusions, and the treated infants received less blood. Serum iron and transferrin saturation percentage dropped significantly during the study and a dose-dependent relationship in treated infants was displayed, suggesting high iron consumption (P = .0008 and P = .006, respectively). No dose effect on hemoglobin level and the need for blood transfusion was found, possibly because of the higher degree of illness severity and iron consumption in groups 2 and 3. No side effects related to rhEPO therapy were observed. CONCLUSIONS: It is concluded that rhEPO therapy is safe in premature babies when given in the three dosages used in this study; in addition, it enhances erythropoiesis and reduces the need for blood transfusions. rhEPO therapy seems more efficient when given in higher dosages; however, illness severity and iron consumption represent major limiting factors. Controlled, randomized studies are warranted to confirm these data and to determine precise modalities and indications of rhEPO therapy in premature infants.