Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)

Inclusion Criteria:

   - Newborns ≥ 36 weeks gestation, < 23 hours of age at time of consent, must meet all 3
   Inclusion Criteria to be eligible for the study:

      1. Perinatal depression = at least one of the following: a) Apgar ≤5 at 10 min or b)
      required resuscitation (endotracheal or mask ventilation, or chest compressions)
      at 10 min or c) pH < 7.0 or base deficit ≥15 in cord, arterial, or venous blood
      obtained at <60 min of age;

      2. Moderate to severe encephalopathy = at least 3 of 6 modified Sarnat criteria
      present between 1-6 h of birth: a) reduced level of consciousness; b) decreased
      spontaneous activity; c) hypotonia; d) decreased suck; e) decreased Moro reflex;
      or f) respiratory distress including periodic breathing or apnea; and

      3. Hypothermia = passive or active cooling begun by 6 hours of age.

Exclusion Criteria:

   - Intrauterine growth restriction (BW <1800 g);

   - Major congenital malformation; suspected genetic syndrome, metabolic disorder or TORCH
   infection;

   - Head circumference < 2 SD for gestation;

   - Infant for whom withdrawal of supportive care is being considered; or

   - Anticipated inability to collect primary endpoint at 12 months of age.