Neonatal Erythropoietin in Asphyxiated Term Newborns

Completed · Phase 1

Conditions studied: Hypoxic-ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00719407

Run by

University of California, San Francisco

People needed

24

Starts

2010-01-01

Expected to finish

2012-11-01

Last updated by the study team

2012-11-09

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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