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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
1000 U/kg/dose IV x 5 doses
placebo: NS IV x 5 doses
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Stanford University
Palo Alto, California, United States
UCSF
San Francisco, California, United States
Kaiser Permanente, Santa Clara
Santa Clara, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Washington University
St Louis, Missouri, United States
Seattle Children's Hospital
Seattle, Washington, United States
Markers of Organ Function
The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Alberta Infant Motor Scale (AIMS)
The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items), \& standing (16 items). Each item is scored as 'observed' or 'not observed'. Total score range is 0-58, scored as percentile ranks after a raw score is obtained and plotted against age at testing, based on validated norms.
Time frame: 12 months
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