ASSESSMENT OF THE SAFETY AND EFFICACY OF DARBEPOIETIN ALFA IN PRETERM INFANTS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Studies evaluating the use of recombinant human erythropoietin (rHuEpo) in preterm infants proved it to be safe and effective. Preterm infants respond to human recombinant erythropoietin (Epo) by increasing reticulocytes, yet the multiple subcutaneous doses diminish its routine use in the NICU. The use of darbepoetin, a slightly modified form of erythropoietin, can be administered once a week or every other week to prevent and treat anemia of prematurity, a promising alternative because the dosing schedule would be more efficacious for extremely small infants. In addition to stimulating red cell production, rHuEpo has been shown to be protective in the developing brain, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. In animal models, darbepoetin shows the same protective effect as rHuEpo, and it is reasonable to postulate that the use of darbepoetin will eliminate the need for transfusion in some preterm infants, and reduce the need in others. We plan to evaluate both hematologic and neurodevelopmental outcomes in preterm infants treated with darbepoetin.