Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00491413
Status:
UNKNOWN
Last Update Posted:
2007-06-26
First Post:
2007-06-22
Brief Title:
Erythropoietin for Infants With Brain Injuries Due to Oxygen Deprivation at Birth
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
High Dose Erythropoietin for Neonates With Asphyxia
Status:
UNKNOWN
Status Verified Date:
2003-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None