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

Primary Purpose

Asphyxia

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

epoetin

About this trial

This is an interventional treatment trial for Asphyxia focused on measuring neurodevelopmental outcomes

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

All Children's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00491413

First Posted

June 22, 2007

Last Updated

June 22, 2007

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00491413

Brief Title

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

Official Title

High Dose Erythropoietin for Neonates With Asphyxia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2003

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asphyxia

Keywords

neurodevelopmental outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

epoetin

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Hours

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert D. Christensen, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

All Children's Hospital

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert D. Christensen, MD

Phone

727-502-8168

rchriste@hsc.usf.edu

First Name & Middle Initial & Last Name & Degree

Stacey M. Levitt, MD

Phone

727-553-1570

slevitt@hsc.usf.edu

12. IPD Sharing Statement

Learn more about this trial

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

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