Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Children's Hospital & Research Center Oakland
University of Washington
Santa Clara Valley Health & Hospital System
Information provided by (Responsible Party):
Yvonne Wu, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00719407
First received: July 17, 2008
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Hypoxic-ischemic Encephalopathy
Drug: erythropoietin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Serious adverse event [ Time Frame: 14 days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 1 to 11 days of life ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719407

Locations
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
Investigators
Principal Investigator: Yvonne W Wu, MD, MPH University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional 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
Study First Received: July 17, 2008
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on July 24, 2014