Hypoxic-ischemic Encephalopathy Clinical Trial
Official title:
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
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.
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.
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