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Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)

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ClinicalTrials.gov Identifier: NCT00719407
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Condition or disease Intervention/treatment Phase
Hypoxic-ischemic Encephalopathy Drug: erythropoietin Phase 1

Detailed Description:
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial
Study Start Date : January 2010
Primary Completion Date : September 2011
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
Drug: erythropoietin
250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)
Other Name: Procrit

Outcome Measures

Primary Outcome Measures :
  1. Serious adverse event [ Time Frame: 14 days of life ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 1 to 11 days of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. ≥ 36 weeks gestational age
  2. Perinatal depression (low Apgar score, need for resuscitation)
  3. Moderate to severe encephalopathy

Exclusion Criteria:

  1. Specific aEEG findings
  2. Intrauterine growth restriction
  3. Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
  4. Microcephaly
  5. Infant older than 23.5 hours of age at the time of consent
  6. Infant judged by an attending physician to be likely to die due to the severity of illness
  7. Polycythemia
  8. Hypertension
  9. No in-dwelling line
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719407

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Thrasher Research Fund
Children's Hospital & Research Center Oakland
University of Washington
Santa Clara Valley Health & Hospital System
Principal Investigator: Yvonne W Wu, MD, MPH University of California, San Francisco
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yvonne Wu, Professor of Neurology and Pediatrics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00719407     History of Changes
Other Study ID Numbers: H9299-32566-01
Thrasher 02827-0
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Yvonne Wu, University of California, San Francisco:
birth asphyxia
neonatal encephalopathy
hypoxic-ischemic encephalopathy

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Epoetin Alfa