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

Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Anemia, Neonatal

Intervention: Erythropoietin (Drug); Sham Comparator (Other)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Robin K. Ohls, MD, Study Director, Affiliation: University of New Mexico
Edward F. Donovan, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Barbara J. Stoll, MD, Principal Investigator, Affiliation: Emory University
Ann R. Stark, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
James A. Lemons, MD, Principal Investigator, Affiliation: Indiana University
Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee
Seetha Shankaran, MD, Principal Investigator, Affiliation: Wayne State University
Richard A. Ehrenkranz, MD, Study Director, Affiliation: Yale University
Raymond Bain, PhD, Principal Investigator, Affiliation: George Washington University

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.

Clinical Details

Official title: The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Preterm Infants 401-1250 Grams: Two Multi-Center, Randomized, Double-Masked, Placebo Controlled Studies

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Erythrocyte transfusions in infants 401-1,000g birthweight

Blood transfusions

Detailed description: Critically ill preterm infants experience in the first 1-2 weeks after birth daily blood losses that may equal 5-10% of their total blood volume. Such losses and associated anemia typically result in multiple erythrocyte transfusions. This iatrogenic anemia commonly is followed by the anemia of prematurity, prompting additional transfusions. 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 (Trial 1), we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight (Trial 2), we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions. Therapy was initiated by day of life 4 and continued through the 35th postmenstrual week. Infants were randomized to receive either Epo and iron therapy or a sham procedure. Treated infants received 400 U/kg 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. Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available. Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were measured monthly. Transfusions were administered according to protocol. Infants did not receive a transfusion solely to replace blood lost through phlebotomy. Infants who met transfusion criteria received a transfusion of 15 mL/kg packed red blood cells (PRBC) for a hematocrit of >25% or 20 mL/kg PRBC for a hematocrit of <=25%. Blood losses and transfusion data were recorded. Trial 2 was terminated after enrollment of 118 infants after the Data and Safety Monitoring Committee reviewed the final results of Trial 1 and preliminary results of Trial 2. On the basis of these data, the Committee concluded that it was statistically unlikely that Trial 2 would demonstrate a significant decrease in the percentage of infants who would receive a transfusion during the study.

Eligibility

Minimum age: N/A. Maximum age: 96 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Infants with a birth weight of 4010-1250g, <32 weeks' gestation, and 24-96 hours old

at the time of study entry

- Likely to survive >72 hours

- Informed consent from a parent or guardian.

Exclusion Criteria:

- Major congenital anomaly

- A positive direct antiglobulin test

- Evidence of coagulopathy

- Clinical seizures

- Systolic blood pressure >100 mm Hg (in the absence of pressor support)

- Absolute neutrophil count (ANC) of <=500/micro-L

Locations and Contacts

Yale University, New Haven, Connecticut 06504, United States

George Washington University, Washington, District of Columbia 20052, United States

Emory University, Atlanta, Georgia 30303, United States

Indiana University, Indianapolis, Indiana 46202, United States

Harvard University, Cambridge, Massachusetts 02138, United States

Wayne State University, Detroit, Michigan 48201, United States

University of New Mexico, Albuquerque, New Mexico 87131, United States

Cincinnati Children's Medical Center, Cincinnati, Ohio 45267, United States

University of Tennessee, Memphis, Tennessee 38163, United States

Additional Information

NICHD Neonatal Research Network

Starting date: August 1997
Last updated: June 3, 2015

Page last updated: August 23, 2015

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