Perinatal HypoxiaNCT05018364
Serum Erythropoietin Level in Perinatal Asphyxia
An observational study of Perinatal Hypoxia, run by Cairo University at 1 site in Egypt.
Trial summary
This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin). Read more about this study
- Who is it for?
- Ages 1 day to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Perinatal Hypoxia
- What is being tested?
- Serum erythropoietin level
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Data will be collected from full-term neonates (first 28 days of life) with perinatal hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males \& females) .
Who may be able to join
- Cases group:
- The presence of a sentinel hypoxic event immediately before or during delivery
- History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
- Need for neonatal resuscitation at delivery
- One-min Apgar score <3 or 5-minApgar score<7
- Metabolic acidosis (BE > 10 in cord blood)
Show all 9Show fewer
- Cardiocirculatory instability (CCI), clinical indications of hypoxic-ischemic encephalopathy (HIE) and multiple organ involvement (MOI).
- Control group:
- Newborns who were delivered normally after uncomplicated pregnancy. None of them have clinical nor biochemical signs of asphyxia.
Who cannot join
- Newborns who do not fulfill the above criteria.
- Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
- Whose parents refuse to participate in the study.
- Cases above 4 days old.
- Preterm neonates (less than 37 weeks).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.
This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).
Read the detailed description
Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.
- Conditions
- Perinatal Hypoxia
- Being tested
- Serum erythropoietin level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum erythropoietin levelDiagnostic test
Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group
| Study group | Role | What they receive |
|---|---|---|
| cases | measure serum erythropoietin level Receives: Diagnostic Test: Serum erythropoietin level | |
| controls | measure serum erythropoietin level Receives: Diagnostic Test: Serum erythropoietin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between serum erythropoietin level and brain injury
measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia
Measured: first 4 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Aug 2020
- Primary completion1 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal HypoxiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ahmed Sayed, Cairo University
- Investigators
- Yosra Aboelnaga, Study chair, Dryosra86@hotmail.comNermine Riad, Study chair, docnermoo@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018364
- Sponsor's protocol ID
- MS-222-2020
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sweetman DU, Onwuneme C, Watson WR, Murphy JF, Molloy EJ. Perinatal Asphyxia and Erythropoietin and VEGF: Serial Serum and Cerebrospinal Fluid Responses. Neonatology. 2017;111(3):253-259. doi: 10.1159/000448702. Epub 2016 Dec 1.
PubMed 27902983
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Erythropoietin Level for Detection of Kidney and Brain Injuries in Asphyxiated Neonates in Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05018364
- Acronym / sponsor ID
- MS-222-2020
- Conditions
- Perinatal Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 24 Aug 2021 (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 to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).
Detailed description
Perinatal hypoxic-ischemic encephalopathy (HIE) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. Acute kidney injury (AKI) occurs in (50 - 72%) among asphyxiated term infants. The kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. These cells make and release erythropoietin when the oxygen level is too low.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: Serum erythropoietin levelmeasure serum erythropoietin level |
| controls | – | Diagnostic Test: Serum erythropoietin levelmeasure serum erythropoietin level |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Data will be collected from full-term neonates (first 28 days of life) with perinatal hypoxia admitted in Neonatal Intensive Care Unit. Both sexes are included (males \& females) .
Key inclusion criteria (9 listed)
- The presence of a sentinel hypoxic event immediately before or during delivery
- History of fetal distress (bradycardia, late decelerations, absence of heart rate variability).
- Need for neonatal resuscitation at delivery
- One-min Apgar score <3 or 5-minApgar score<7
- Metabolic acidosis (BE > 10 in cord blood)
Key exclusion criteria (5 listed)
- Newborns who do not fulfill the above criteria.
- Newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection.
- Whose parents refuse to participate in the study.
- Cases above 4 days old.
- Preterm neonates (less than 37 weeks).
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 |
|---|---|---|
| Serum erythropoietin levelEvaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group | Diagnostic test | cases, controls |
Primary outcome
correlation between serum erythropoietin level and brain injury
Time frame: first 4 days of life
measure level of serum erythropoietin by ELISA technique and test if can differentiate degree of brain hypoxia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 27902983Sweetman DU, Onwuneme C, Watson WR, Murphy JF, Molloy EJ. Perinatal Asphyxia and Erythropoietin and VEGF: Serial Serum and Cerebrospinal Fluid Responses. Neonatology. 2017;111(3):253-259. doi: 10.1159/000448702. Epub 2016 Dec 1.
Related trials for Perinatal Hypoxia
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The HIEnome Study: Genome Sequencing for Perinatal HIE
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
Not yet recruitingPhase 2/3
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke
Not yet recruitingPhase 1/2
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
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. This study is not recruiting at the moment.
Yosra Aboelnaga study chair
Dryosra86@hotmail.com
Nermine Riad study chair
docnermoo@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perinatal Hypoxia, run by Cairo 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 30 Aug 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between serum erythropoietin level and brain injury (time frame: first 4 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018364, which also lists 1 linked publication.
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 30 Aug 2021.