An Early Phase 1 interventional study of Erythropoietin in Neonatal Hypoxic Ischemic Encephalopathy, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Day to 1 Month. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Assiut University · Early Phase 1, Interventional, and Prevention
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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?
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 (e.g., hypoxia) . EPO's 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 IU/kg body weight are administered either early or late for prolonged periods of time. These high doses are well tolerated in preterm infants (i.e., 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 .
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 3 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Erythropoietin was administered in the first weeks of life at different multiple doses between 259-1000 UI/KG/D for 3 days
Drug: Erythropoietin
EPO reduces the need for blood transfusions in premature infants. To cross the blood-brain barrier
Drug: Erythropoietin
prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation
the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy
oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietin
EPO provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions e.g., hypoxia
Time frame: Baseline
Plan to share: No
Start is estimated for Nov 2024; primary completion for Feb 2029, 51 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erythropoietin