Neonatal Erythropoietin in Asphyxiated Term Newborns

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Children's Hospital & Research Center Oakland; Santa Clara Valley Health & Hospital System; Thrasher Research Fund; UCSF Benioff Children's Hospital Oakland; University of Washington
• Treatments: Epoetin Alfa

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