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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Not yet recruiting
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: June 22, 2007
Last updated: NA
Last verified: August 2003
History: No changes posted
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 Intervention Phase
Drug: epoetin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Erythropoietin for Neonates With Asphyxia

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 15
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.


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
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Please refer to this study by its identifier: 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   
Contact: Stacey M. Levitt, MD    727-553-1570   
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 Identifier: NCT00491413     History of Changes
Other Study ID Numbers: R21HD042308 ( US NIH Grant/Contract Award Number )
Study First Received: June 22, 2007
Last Updated: June 22, 2007

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
Hematinics processed this record on May 22, 2017