Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
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.
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.
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.
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.
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
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