Overview

High-dose Erythropoietin for Asphyxia and Encephalopathy

Status:
Active, not recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Boston University
Children's Hospital Los Angeles
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Children's National Research Institute
Children's Research Institute
Cook Children's Medical Center
Indiana University
Johns Hopkins University
Mednax Center for Research, Education and Quality
Mednax Center for Research, Education, Quality and Safety
Nationwide Children's Hospital
Northwestern
Stanford University
University of California, Davis
University of Chicago
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
University of New Mexico
University of North Carolina
University of Pittsburgh
University of Texas
University of Utah
University of Washington
Vanderbilt University
Washington University School of Medicine
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- ≥ 36 weeks of gestational age

- Receiving active or passive whole body cooling/hypothermia since < 6 hours of age

- Perinatal depression based on at least one of the following:

1. Apgar score < 5 at 10 minutes, or

2. Need for resuscitation at 10 minutes (i.e., chest compressions, or positive
pressure respiratory support including endotracheal, mask ventilation, or CPAP),
or

3. pH < 7.00 in cord gas (arterial or venous) or in an infant gas (arterial or
venous) obtained at < 60 minutes of age, or

4. Base deficit ≥ 15 mmol/L in cord gas (arterial or venous) or in an infant gas
(arterial or venous) obtained at < 60 minutes of age

- Moderate to severe encephalopathy (based on modified Sarnat exam) present between 1-6
hours after birth

Exclusion Criteria:

- Study drug unlikely to be administered within 26 hours of birth

- Infant has living twin (or higher order multiple) who is also being cooled

- Birth weight < 1800 g (e.g., intrauterine growth restriction)

- Genetic or congenital condition that affects neurodevelopment or requires multiple
surgeries (e.g., congenital viral infection, hydrops, complex congenital heart
disease, severe dysmorphic features, etc.)

- Head circumference < 30 cm

- Redirection of care is being considered due to moribund condition

- Patient anticipated to be unavailable for evaluation at age 2

- Polycythemia (hematocrit > 65.0%)

- Parents/legal guardians with diminished capacity and autonomy

- Infant is participating or intends to participate in another interventional study
during the birth hospitalization (note: does not include observational studies)

- Sentinel event and encephalopathy occurred only after birth

- Unable to consent in primary language of parent(s)