High-dose Erythropoietin for Asphyxia and Encephalopathy

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)