Overview

Darbepoetin Administration to Preterm Infants

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
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
Accepts Healthy Volunteers?
No
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
Treatments:
Darbepoetin alfa
Epoetin Alfa
Criteria
Inclusion Criteria:

- 500-1250 grams birth weight

- less than or equal to 32 weeks gestation

- less than 2 days of age

Exclusion Criteria:

- severe hemorrhagic disease

- severe hemolytic disease

- DIC

- seizures

- hypertension

- thromboses

- receiving erythropoietin