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

NCT ID: NCT00491413

Last Updated: 2007-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asphyxia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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epoetin

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Robert D. Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Countries

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United States

Facility Contacts

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Robert D. Christensen, MD

Role: primary

[email protected]
727-502-8168

Stacey M. Levitt, MD

Role: backup

[email protected]
727-553-1570

Other Identifiers

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R21HD042308

Identifier Type: NIH

Identifier Source: org_study_id

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