Trial record 13 of 129 for:    oxygen therapy OR supplemental oxygen | Open Studies | NIH, U.S. Fed

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00491413
First received: June 22, 2007
Last updated: NA
Last verified: August 2003
History: No changes posted
  Purpose

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
Asphyxia
Drug: epoetin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491413

Locations
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
Investigators
Principal Investigator: Robert D. Christensen, MD University of South Florida
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00491413     History of Changes
Other Study ID Numbers: R21HD42308
Study First Received: June 22, 2007
Last Updated: June 22, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014