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Erythropoietin in HIE Neonate

Role of Erythropoietin in Neonates With Hypoxic Ischemic Encephalopathy

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06590155
Enrollment
3
Registered
2024-09-19
Start date
2024-11-24
Completion date
2029-02-24
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

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 .

Interventions

DRUGErythropoietin

the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietinBaselineEPO provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions e.g., hypoxia

Countries

Egypt

Contacts

Primary ContactShimaa fahmy, residant
Shimaasaberfahmy1197@gmail.com01001483064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026