Erythropoietin in HIE Neonate

NCT ID: NCT06590155

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-24
• Study Completion Date: 2029-02-24

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 (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 .

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Erythropoietin was administered in the first weeks of life at different multiple doses between 259-1000 UI/KG/D for 3 days

Group Type: EXPERIMENTAL

Erythropoietin

Intervention Type: DRUG

the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Role of Erythropoietin in neonate hypoxic ishemic encephalopathy

EPO reduces the need for blood transfusions in premature infants. To cross the blood-brain barrier

Group Type: OTHER

Erythropoietin

Intervention Type: DRUG

the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Role of Erythropoietin in neonatal hypoxic ischemic encephalopathy

prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Erythropoietin

the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• neonates who less than 1 month suffer from hypoxic ischemic encephalopathy

Exclusion Criteria

• neonates who more than 1 month
• neonates who suffer from brain insults other than HIE

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shimaa Saber Fahmy

resident doctor at internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university children hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

Shimaa fahmy, residant

Role: CONTACT

Shimaasaberfahmy1197@gmail.com

01001483064

Related Links

https://www.frontiersin.org/articles/10.3389/fped.2022.1074287/full

Erythropoietin: a novel therapy for hypoxic-ischaemic encephalopathy

https://www.degruyter.com/document/doi/10.1515/jpm-2018-0360/html

Erythropoietin in perinatal hypoxic-ischemic

Other Identifiers

Erythropoietin in HIE neonate

Identifier Type: -

Identifier Source: org_study_id