ClinicalTrials.gg
Not yet recruitingNCT06590155Updated Sep 19, 2024

Erythropoietin in HIE Neonate

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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Phase
Early Phase 1
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
1 Day to 1 Month
Sex
All
01

Study 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?

Read the 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 .

02

Conditions studied

  • Neonatal Hypoxic Ischemic Encephalopathy
03

In context

Hypoxia-Ischemia, Brain

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • neonates who more than 1 month
  • neonates who suffer from brain insults other than HIE
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Erythropoietin

  • Other
    Role of Erythropoietin in neonate hypoxic ishemic encephalopathy

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

    Drug: Erythropoietin

  • No intervention
    Role of Erythropoietin in neonatal hypoxic ischemic encephalopathy

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

Interventions

  • the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy

06

What researchers measure

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

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2024; primary completion for Feb 2029, 51 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2024
First posted
Sep 19, 2024
StartEst.
Nov 24, 2024
Primary completionEst.
Feb 24, 2029
CompletionEst.
Feb 24, 2029
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06590155
Lead sponsor
Assiut University
Responsible party
Shimaa Saber Fahmy (resident doctor at internal medicine department, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Nov 24, 2024 (estimated)
Primary completion
Feb 24, 2029 (estimated)
Completion
Feb 24, 2029 (estimated)
Last update
Sep 19, 2024

Study contacts

Shimaa fahmy, residant
Contact
Shimaasaberfahmy1197@gmail.com
01001483064

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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