Clinical Trial: Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
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 Summary:
This phase I/II clinical trial is designed to demonstrate:
- 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.
- The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ function and general growth parameters.
- The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function at 12 months of age.
Sponsor: University of California, San Francisco
Current Primary Outcome: Markers of organ function [ Time Frame: Participants will be followed for the duration of hospital stay, an expected averaged of 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Alberta Infant Motor Score (AIMS) [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: July 29, 2013
Date Started: September 2013
Date Completion: September 2016
Last Updated: March 14, 2016
Last Verified: March 2016