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CompletedNCT00719407NEATUpdated Nov 9, 2012

Neonatal Erythropoietin in Asphyxiated Term Newborns

A Phase 1 interventional study of erythropoietin in Hypoxic-ischemic Encephalopathy, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
Up to 24 Hours
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypoxic-ischemic Encephalopathy

Keywords

  • birth asphyxia
  • neonatal encephalopathy
  • hypoxic-ischemic encephalopathy
  • neuroprotection
  • neonate
03

In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's enrollment of 24 is below the median of 58 across 454 interventional studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥ 36 weeks gestational age
  2. Perinatal depression (low Apgar score, need for resuscitation)
  3. Moderate to severe encephalopathy

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    A

    All enrolled patients will be in this single arm, who will receive experimental drug treatment.

    Drug: erythropoietin

Interventions

  • Drugerythropoietin

    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)

    Also known as: Procrit

06

What researchers measure

Primary outcomes

  1. Serious adverse event

    Time frame: 14 days of life

Secondary outcomes

  1. Pharmacokinetic parameters

    Time frame: 1 to 11 days of life

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

References and documents

Publications

  • Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27. PubMed 25439577 ↗
  • Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008. PubMed 24524452 ↗
  • Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24. PubMed 23008465 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00719407
Lead sponsor
University of California, San Francisco
Collaborators
Thrasher Research Fund, UCSF Benioff Children's Hospital Oakland, University of Washington, Santa Clara Valley Health & Hospital System
Responsible party
Yvonne Wu (Professor of Neurology and Pediatrics, University of California, San Francisco) — Principal investigator
First posted
Jul 21, 2008
Start date
Jan 2010
Primary completion
Sep 2011
Completion
Nov 2012
Last update
Nov 9, 2012

Study contacts

Yvonne W Wu, MD, MPH
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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