NCT01913340

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

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 30 Minutes – 24 Hours
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hypoxic-ischemic Encephalopathy
• Neonatal Encephalopathy
• Birth Asphyxia

Interventions

Type	Name	Description
DRUG	Erythropoietin	1000 U/kg/dose IV x 5 doses
DRUG	Normal saline	placebo: NS IV x 5 doses

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-01-01
• Completion: 2016-09-01
• First posted: 2013-08-01
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study