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

June 22, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

High Dose Erythropoietin for Neonates With Asphyxia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Robert D. Christensen, MD, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 26, 2007

Last Update Submitted That Met QC Criteria

June 22, 2007

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21HD042308 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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