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:

  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.

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 ]

The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit


Original Primary Outcome: Same as current

Current Secondary Outcome: Alberta Infant Motor Score (AIMS) [ Time Frame: 12 months ]

The instrument contains 58 items that are broken down into 4 motor sub-scales: prone, supine, sit and stand. The assessment entails observation only with minimal handling, and is typically completed in 10-20 minutes.


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