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Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) — NEATO  

Hypoxic-ischemic Encephalopathy Clinical Trial

Official title:
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01913340
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2013
Completion date September 2016
View Details
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