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Reference Library HomeEffects of a Combined Therapy Of Erythropoietin, Iron, Folate, and Vitamin B12 on the Transfusion Requirements of Extremely Low Birth Weight Infants
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Date Posted: Friday, November 17th, 2006
| Haiden N, Schwindt J, Cardona F, Berger A, Klebermass K, Wald M, Kohlhauser-Vollmuth C, Jilma B, Pollak A. Pediatrics. 2006 Nov;118(5):2004-13. Department of Pediatrics, Division of Neonatology and Intensive Care, Medical University of Vienna, Wahringer Gurtel 18-20, 1090 Vienna, Austria. |
| Abstract Here |
| Summary |
| Studies in extremely low birth weight (ELBW) infants have yielded mixed and disappointing results with regard to erythropoietin therapy reducing transfusion requirements. This randomized controlled trial by Haiden and colleagues found combined therapy with erythropoietin, intravenous (IV) iron, high-dose folate and vitamin B12 reduced the transfusion rate by one third compared with controls in ELBW infants (68% transfused in the treatment group versus 95% in the control group). Forty infants with birth weight ≤ 800 g (range 450 to 800 g) and a gestational age of ≤ 32 weeks were randomly assigned to one of 2 groups, a treatment group and a control group. The treatment group received from the second day of life erythropoietin (2100 IU/kg/wk), iron (1.5 mg/kg/d IV and once on full enteral feedings, 9 mg/kg/d orally) and vitamin B12 (3 µg/kg/d IV and once on full enteral feedings, 21 µg/kg/wk subcutaneously). Folic acid (100 µg/kg/d orally) was started on the 15th day of life or when the infant tolerated enteral feedings of a set dose, whichever came first. The control group received iron (9 mg/kg/d orally) and folic acid (100 µg/kg/d orally) either from day 15 of life or when enteral feedings were tolerated, whichever came first. Patient demographics and clinical characteristics were similar between groups with the exception of there being an imbalance between infants on mechanical ventilators (two-fold higher in the treatment group). A standard transfusion protocol was adhered to. Prior to the study, the authors estimated from their institution’s data that up to 90% of this patient population would likely require transfusion, requiring a total of 40 patients for the sample size to have sufficient power to detect a significant reduction in infants requiring transfusion. Results: 62% in the treatment group received transfusions compared with 95% in the control group, representing a significant reduction in the proportion of infants transfused (P=.013). The authors suggest that 3 outliers in the treatment group with prolonged ventilation and high transfusion requirements (the transfusion protocol was linked to respiratory support), meant the reduced average number of transfusions (2.0 versus 4.5) and cumulative average volume transfused (28 mL versus 75 mL) in the treatment group compared with controls did not reach statistical significance. Hematocrits decreased in both groups during the study period, but were lower in the control group. Reticulocyte counts were significantly higher in the treatment group. Ferritin levels increased significantly more over baseline in the treatment group and transferrin receptors increased in the treatment group, but decreased in the control group. Red blood cell folate and vitamin B12 also increased significantly in the treatment group compared with controls. However, the authors suggest their folic acid and B12 dose may still be insufficient in this setting of erythropoietin therapy. Multivariate analysis indicated that days on the ventilator increased the risk for transfusion, and their combined therapy was associated with a 79% risk reduction for any transfusion. The investigators conclude that this combined treatment regimen enhances erythropoiesis and reduces transfusion requirements in ELBW infants compared with controls. |