Darbepoetin Administration to Preterm Infants

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.

Conditions

• Infant, Newborn

Interventions

DRUG

Darbepoetin Alfa Injection

darbepoetin alfa injection 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

DRUG

erythropoietin alfa injection

Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

DRUG

sham injection

sham injection other names: not applicable

Sponsors & Collaborators

• Thrasher Research Fund

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• University of New Mexico

  lead OTHER

Principal Investigators

• Robin K Ohls, MD · University of New Mexico

• Robert D Christensen, MD · McKay-Dee Hospital, Ogden, Utah

• Susan Wiedmeier, MD · LDS Hospital, Salt Lake City, Utah

• Adam Rosenberg, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Hour

Max Age

49 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2013-12-31

Completion

2014-06-30

Countries

• United States

Study Locations