Neonatal Erythropoietin in Asphyxiated Term Newborns

Phase 1

Completed

• Conditions: Hypoxic-ischemic Encephalopathy
• Interventions: Drug: erythropoietin

• Registration Number: NCT00719407
• Lead Sponsor: University of California, San Francisco

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 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 Timeline

• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Study Start: 2010-01
• Primary Completion: 2011-09
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	erythropoietin	All enrolled patients will be in this single arm, who will receive experimental drug treatment.

Primary Outcome Measures

Name	Time	Method
Serious adverse event	14 days of life

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	1 to 11 days of life

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States