Neonatal Erythropoietin in Asphyxiated Term Newborns

Hypoxic-ischemic Encephalopathy Clinical Trial

— NEAT  

Official title:

Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719407
• Other study ID #: H9299-32566-01
• Secondary ID: Thrasher 02827-0
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2008
• Last updated: November 7, 2012
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-ischemic Encephalopathy

Intervention

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)

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Children's Hospital & Research Center Oakland, Santa Clara Valley Health & Hospital System, Thrasher Research Fund, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse event		14 days of life	Yes
Secondary	Pharmacokinetic parameters		1 to 11 days of life	No