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

NCT01913340 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-07-13

Study results available
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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.

Conditions

  • Hypoxic-ischemic Encephalopathy
  • Neonatal Encephalopathy
  • Birth Asphyxia

Interventions

DRUG

Erythropoietin

1000 U/kg/dose IV x 5 doses

DRUG

Normal saline

placebo: NS IV x 5 doses

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • Arkansas Children's Hospital Research Institute

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Children's National Research Institute

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Yvonne W Wu, MD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-01-31
Completion
2016-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913340 on ClinicalTrials.gov