Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590155
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-24
Brief Title:
Erythropoietin in HIE Neonate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of Erythropoietin in Neonates With Hypoxic Ischemic Encephalopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
this study is aim to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy the study is conducted to answer the question is erythropoietin will improve neonatal hypoxic ischemic encephalopathy
Detailed Description:
Hypoxic-ischemic encephalopathy HIE remains a major cause of morbidity and mortality HIE causes 23 of neonatal deaths Erythropoietin is a 34kDa glycoprotein that was originally identified because of its role in erythropoiesis In the fetus EPO is produced in the liver and following the neonatal period EPO is produced in the kidney and the liver EPO is a cytokine with pleiotropic functions including erythropoiesis modulation of inflammatory and immune responses EPO and the EPO receptor EPO-R are expressed by a variety of cell types in the brain including neuronal progenitor cells EPO transport across the blood-brain barrier is limited by its large size Only 1 to 2 of circulating EPO crosses the blood-brain barrier under normal circumstances most likely via passive diffusion EPO provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions eg hypoxia EPOs main role is to prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation The use of EPO reduces the need for blood transfusions in premature infants To cross the blood-brain barrier high doses at 2000 to 5000 IUkg body weight are administered either early or late for prolonged periods of time These high doses are well tolerated in preterm infants ie EPO is safe and devoid of untoward complications in this context In previos studies The first dose of r-Hu-EPO was administered at 1 to 48 h after birth followed by doses every other day for 2 weeks At 18 months-of-age neurodevelopmental outcomes were assessed Improved long-term outcomes in the r-Hu-EPO-treated infants were evident after moderate HIE but not in those with severe HIE There were no side-effects from r-HuEPO treatment
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