Trial Search Results

High-dose Erythropoietin for Asphyxia and Encephalopathy

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

University of California, San Francisco

Collaborator: Children's Hospital Medical Center, Cincinnati

Stanford Investigator(s):


  • Drug: Normal saline placebo
  • Drug: Erythropoietin


Phase 3


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., endotracheal or mask ventilation, or
      chest compressions), or

      3. pH < 7.00 in cord, arterial, or venous blood < 60 minutes of age

      4. Base deficit ≥ 15 mmol/L in cord, arterial, or venous blood < 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%)

   - Parents with diminished capacity and autonomy

   - Infant is participating in another interventional study (note: does not include
   observational studies)

Ages Eligible for Study

N/A - 24 Hours

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa Van Meurs, MD
Not Recruiting