Conditions: Hypoxic-ischemic Encephalopathy Neonatal Encephalopathy Birth Asphyxia
Keywords: erythropoietin therapeutic hypothermia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

Detailed description:
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.

Arms:
arm 1: 1000 U/kg/dose x 5 doses arm 2: None

Interventions: intervention 1: Erythropoietin intervention 2: Normal saline
Intervention descriptions: intervention 1: 1000 U/kg/dose IV x 5 doses intervention 2: placebo: NS IV x 5 doses

Protocol document: