High-dose Erythropoietin for Asphyxia and Encephalopathy

Summary

Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including cerebral palsy and cognitive impairment in up to half of affected infants. This clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual therapy) will improve outcomes for infants suffering from HIE.

Conditions

• Neonatal Encephalopathy
• Birth Asphyxia

Interventions

DRUG

Normal saline placebo

Equal volume of normal saline to be used as placebo

DRUG

Erythropoietin

Epogen drawn from commercially available single dose 4000U/mL vials

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• Pediatrix

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Boston University

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Cook Children's Medical Center

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Yvonne Wu, MD MPH · University of California, San Francisco

• Sandra Juul, MD PHD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2021-10-31

Completion

2022-04-30

Countries

• United States

Study Locations