Status:
COMPLETED
Neonatal Erythropoietin in Asphyxiated Term Newborns
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Thrasher Research Fund
UCSF Benioff Children's Hospital Oakland
Conditions:
Hypoxic-ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
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.
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 th...
Eligibility Criteria
Inclusion
- ≥ 36 weeks gestational age
- Perinatal depression (low Apgar score, need for resuscitation)
- Moderate to severe encephalopathy
Exclusion
- Specific aEEG findings
- Intrauterine growth restriction
- Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
- Microcephaly
- Infant older than 23.5 hours of age at the time of consent
- Infant judged by an attending physician to be likely to die due to the severity of illness
- Polycythemia
- Hypertension
- No in-dwelling line
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00719407
Start Date
January 1 2010
End Date
November 1 2012
Last Update
November 9 2012
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143