The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Very Low Birth Weight Infants

Summary

This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Anemia, Neonatal

Interventions

DRUG

Erythropoietin

Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.

OTHER

Sham Comparator

Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Robin K. Ohls, MD · University of New Mexico

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Barbara J. Stoll, MD · Emory University

• Ann R. Stark, MD · Brigham and Women's Hospital

• James A. Lemons, MD · Indiana University

• Sheldon B. Korones, MD · University of Tennessee

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Raymond Bain, PhD · George Washington University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

24 Hours

Max Age

96 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1997-08-31

Primary Completion

1998-08-31

Completion

2000-08-31

Countries

• United States

Study Locations