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Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth

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ClinicalTrials.gov Identifier: NCT00491413
Recruitment Status : Unknown
Verified August 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
Information provided by:

Study Description
Brief Summary:
Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

Condition or disease Intervention/treatment Phase
Asphyxia Drug: epoetin Phase 1

Detailed Description:

Damage to the central nervous system as a result of oxygen deprivation at birth is a major cause of life-long mental and developmental handicaps. When there is not enough oxygen in the blood (hypoxemia) the brain is deprived of oxygen. Some brain cells respond by producing Epo. Epo then binds to oxygen-deprived brain cells. This binding triggers chemical reactions within the brain cell that prevent cell death. Epo also reduces inflammation around the brain cells and acts as an antioxidant. In animal studies, recombinant Epo (rEpo) administration, even up to six hours after oxygen deprivation, reduced subsequent brain injury by 50% to 70%.

Epo has been used by neonatologists to stimulate erythropoiesis (red blood cell production) and reduce the incidence of blood transfusions. Doses of rEpo required for protection of brain cells are considerably higher than those traditionally used by neonatologists.

This study will evaluate the pharmacokinetics, biologic effect, and safety of high dose Epo in neonates with brain injury due to hypoxemia.

Within six hours of birth, each eligible infant will receive one dose of rEpo intravenously. Any infants who require a lumbar puncture during the first week of life will have levels of natural Epo and rEpo in their spinal fluid measured. Blood tests will be used to measure the antioxidant effect of Epo and the impact on red blood cell production. Neurodevelopmental outcome will be measured at 6 and 12 months of age.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Erythropoietin for Neonates With Asphyxia

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Infant 6 hours of age or less
  • Apgar scores less than or equal to 3 at 1 and 5 minutes
  • Weight greater than 2500 grams (5.5 lbs)
  • Central venous line in place

Exclusion Criteria

  • infants are ineligible if they do not meet the inclusion criteria above
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491413

United States, Florida
All Children's Hospital Not yet recruiting
St. Petersburg, Florida, United States, 33701
Contact: Robert D. Christensen, MD    727-502-8168    rchriste@hsc.usf.edu   
Contact: Stacey M. Levitt, MD    727-553-1570    slevitt@hsc.usf.edu   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Robert D. Christensen, MD University of South Florida
More Information

ClinicalTrials.gov Identifier: NCT00491413     History of Changes
Other Study ID Numbers: R21HD042308 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: August 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
neurodevelopmental outcomes

Additional relevant MeSH terms:
Pathologic Processes
Wounds and Injuries
Epoetin Alfa