Infants born prematurely do not increase production of the primary red cell growth factor,
erythropoietin (Epo), and often develop an anemia called the "anemia of prematurity." The
anemia of prematurity is the most common anemia seen in neonates, and is due to a failure of
Epo production. Human recombinant Epo (rHuEpo), given three to five times a week, is
successful in treating the anemia of prematurity. A slightly modified, long-acting version of
rHuEpo, called darbepoetin alfa (darbepoetin), is now available and has proven effective in
increasing hematocrit (red blood cell levels) in adults. In addition to its red cell
stimulating properties, recent evidence has shown that rHuEpo is protective in the developing
or injured brain. We have designed a randomized, masked, placebo-controlled study to
determine the safety and short and long term efficacy of darbepoetin. At this time,
darbepoetin has been studied primarily in adults and pediatric patients, but there is
evidence from pilot studies that darbepoetin would be useful in the neonatal setting as well.
It also may well improve neurodevelopmental outcomes in preterm neonates. We hypothesize
that: 1. The administration of darbepoetin to preterm infants 500 to 1,250 grams birth weight
will result in increased reticulocyte counts and decreased transfusions compared to placebo;
and 2. The administration of darbepoetin will be associated with an increased mental
developmental index at 18-22 months compared to placebo.
Phase:
Phase 2
Details
Lead Sponsor:
University of New Mexico
Collaborators:
Intermountain Health Care (IHC) LDS Hospital Intermountain Health Care (IHC) McKay-Dee Hospital Intermountain Health Care, Inc. Thrasher Research Fund University of Colorado, Denver