Erythropoietin in HIE Neonate

NCT06590155 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Erythropoietin in HIE neonate
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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?

Conditions

Neonatal Hypoxic Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Study Arms (3)

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

EXPERIMENTAL

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

Drug: Erythropoietin

Role of Erythropoietin in neonate hypoxic ishemic encephalopathy

OTHER

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

Drug: Erythropoietin

Role of Erythropoietin in neonatal hypoxic ischemic encephalopathy

NO INTERVENTION

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

Interventions

Erythropoietin DRUG

the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Role of Erythropoietin in neonate hypoxic ishemic encephalopathy; to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university children hospital

Asyut, 71511, Egypt

Location

Related Links

• Erythropoietin: a novel therapy for hypoxic-ischaemic encephalopathy
• Erythropoietin in perinatal hypoxic-ischemic

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Shimaa fahmy, residant

CONTACT

01001483064; Shimaasaberfahmy1197@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at internal medicine department

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: September 19, 2024
• Study Start: November 24, 2024
• Primary Completion (Estimated): February 24, 2029
• Study Completion (Estimated): February 24, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)