Neonatal Hypoxic Ischemic EncephalopathyEarly Phase 1NCT06590155
Erythropoietin in HIE Neonate
A Early Phase 1 study testing Erythropoietin in people with Neonatal Hypoxic Ischemic Encephalopathy, run by Assiut University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Neonatal Hypoxic Ischemic Encephalopathy
- What is being tested?
- Erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Nov 2024to 24 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates who less than 1 month suffer from hypoxic ischemic encephalopathy
Who cannot join
- neonates who more than 1 month
- neonates who suffer from brain insults other than HIE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Erythropoietin in Neonates With Hypoxic Ischemic Encephalopathy
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 .
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
- Being tested
- Erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Nov 2024 (estimated)
- Primary completion24 Feb 2029 (estimated)
- Study completion24 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Saber Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590155
- Sponsor's protocol ID
- Erythropoietin in HIE neonate
- Status last verified
- Sep 2024
- First submitted
- 24 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Erythropoietin in Neonates With Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT06590155
- Acronym / sponsor ID
- Erythropoietin in HIE neonate
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Nov 2024 (estimated)
- Primary completion
- 24 Feb 2029 (estimated)
- Study completion
- 24 Feb 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy | Experimental | Drug: ErythropoietinErythropoietin was administered in the first weeks of life at different multiple doses between 259-1000 UI/KG/D for 3 days |
| Role of Erythropoietin in neonate hypoxic ishemic encephalopathy | Other | Drug: ErythropoietinEPO reduces the need for blood transfusions in premature infants. To cross the blood-brain barrier |
| Role of Erythropoietin in neonatal hypoxic ischemic encephalopathy | No intervention | –prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- neonates who less than 1 month suffer from hypoxic ischemic encephalopathy
Key exclusion criteria (2 listed)
- neonates who more than 1 month
- neonates who suffer from brain insults other than HIE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoietinthe role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy | Drug | Role of Erythropoietin in neonate hypoxic ishemic encephalopathy, to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy |
Primary outcome
oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietin
Time frame: Baseline
EPO provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions e.g., hypoxia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Erythropoietin: a novel therapy for hypoxic-ischaemic encephalopathyLink provided by the sponsor.
- Erythropoietin in perinatal hypoxic-ischemicLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Neonatal Hypoxic Ischemic Encephalopathy
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
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A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
RecruitingObservational study
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Erythropoietin in people with Neonatal Hypoxic Ischemic Encephalopathy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimaa fahmy, residant (01001483064, Shimaasaberfahmy1197@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietin (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.