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

This phase I/II clinical trial is designed to demonstrate:

1. The feasibility of recruiting, enrolling and following 50 patients with moderate to
severe HIE at 5 sites, while meeting specified recruitment and follow-up target goals.

2. The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ
function and general growth parameters.

3. The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function
at 12 months of age.

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.