EndocanNCT07154134
Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
An observational study of Endocan and Copeptin, run by Tanta University at 1 site in Egypt.
Trial summary
This work aims to investigate and compare the levels of serum endocan and serum copeptin on the first day of life and correlate their levels to the severity of respiratory distress in preterm neonates suffering from respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- What is being tested?
- Serum endocan and Serum copeptin
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2025to 1 Nov 2025
- Phase
- Observational
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This prospective study will be conducted at the Neonatal Intensive Care Unit (NICU), Pediatric Department, Tanta University Hospitals.
Who may be able to join
- Prematurity.
- Gestational age between 28 and 36 weeks.
- Suffering from respiratory distress syndrome.
Who cannot join
- Intrauterine growth restriction (IUGR).
- Hypoxic ischemic encephalopathy.
- Multiple congenital anomalies.
- Chromosomal abnormalities.
- Preterm less than 28 weeks.
- Neonates with a maternal history of chorioamnionitis (early sepsis).
- Infant of diabetic mother.
- Prelabor rupture of membranes (PROM)> 2 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Asmaa M Elmesiry, MD, 00201224285567, asmaa.elmesery@med.tanta.edu.eg
About this study
Official title: Comparative Study Between Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
This work aims to investigate and compare the levels of serum endocan and serum copeptin on the first day of life and correlate their levels to the severity of respiratory distress in preterm neonates suffering from respiratory distress syndrome.
Read the detailed description
Preterm birth continues to be one of the significant challenges in perinatal medicine because of its high incidence of morbidities and mortalities. Its burden on the infant, the family, healthcare systems, and society is enormous.
Endocan is implicated in the recruitment of circulating lymphocytes to inflammatory sites and leukocyte adhesion and activation. Endocan also inhibits leukocyte-endothelial cell adhesion and reduces the excessive leukocyte recruitment into the lungs.
Copeptin, also known as the arginine vasopressin (AVP) associated glycopeptides. AVP is a vasoactive neurohypophysial hormone. It is one of the primary hormones of the hypothalamic-pituitary-adrenal axis, and its primary function is to regulate water and maintain electrolyte homeostasis. The primary stimulus for AVP release is hyperosmolarity.
- Conditions
- Endocan, Copeptin, Serum, Preterm Neonates, Respiratory Distress Syndrome
- Being tested
- Serum endocan, Serum copeptin
- Medical subject headings
- Diabetes Insipidus, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum endocanDiagnostic test
Serum endocan will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.
Serum copeptinDiagnostic test
Serum copeptin will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Neonates with gestational ages between 28 and 34 gestational weeks. Receives: Diagnostic Test: Serum endocan; Diagnostic Test: Serum copeptin | |
| Group II | Neonates with gestational ages between 34 and 36 gestational weeks. Receives: Diagnostic Test: Serum endocan; Diagnostic Test: Serum copeptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum endocan level for prediction of severity of respiratory distress syndrome
Serum endocan level for prediction of severity of respiratory distress syndrome (RDS) will be recorded.
Measured: First day of life
Secondary outcomes (3)
Serum copeptin level for prediction of severity of respiratory distress syndrome
Serum copeptin level for the prediction of the severity of respiratory distress syndrome (RDS) will be recorded.
Measured: 5th day of life
Serum endocan level for prediction of mortality
Serum endocan level for prediction of mortality will be recorded.
Measured: First day of life
Serum copeptin level for prediction of mortality
Serum copeptin level for prediction of mortality will be recorded.
Measured: 5th day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start10 Jul 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocanStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Abdel Hamid Elmesiry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154134
- Sponsor's protocol ID
- 36264PR1296/7/25
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07154134
- Acronym / sponsor ID
- 36264PR1296/7/25
- Conditions
- Endocan, Copeptin, Serum, Preterm Neonates, Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 4 Sep 2025 (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 work aims to investigate and compare the levels of serum endocan and serum copeptin on the first day of life and correlate their levels to the severity of respiratory distress in preterm neonates suffering from respiratory distress syndrome.
Detailed description
Preterm birth continues to be one of the significant challenges in perinatal medicine because of its high incidence of morbidities and mortalities. Its burden on the infant, the family, healthcare systems, and society is enormous.
Endocan is implicated in the recruitment of circulating lymphocytes to inflammatory sites and leukocyte adhesion and activation. Endocan also inhibits leukocyte-endothelial cell adhesion and reduces the excessive leukocyte recruitment into the lungs.
Copeptin, also known as the arginine vasopressin (AVP) associated glycopeptides. AVP is a vasoactive neurohypophysial hormone. It is one of the primary hormones of the hypothalamic-pituitary-adrenal axis, and its primary function is to regulate water and maintain electrolyte homeostasis. The primary stimulus for AVP release is hyperosmolarity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Serum endocan, Diagnostic Test: Serum copeptinNeonates with gestational ages between 28 and 34 gestational weeks. |
| Group II | – | Diagnostic Test: Serum endocan, Diagnostic Test: Serum copeptinNeonates with gestational ages between 34 and 36 gestational weeks. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This prospective study will be conducted at the Neonatal Intensive Care Unit (NICU), Pediatric Department, Tanta University Hospitals.
Key inclusion criteria (3 listed)
- Prematurity.
- Gestational age between 28 and 36 weeks.
- Suffering from respiratory distress syndrome.
Key exclusion criteria (8 listed)
- Intrauterine growth restriction (IUGR).
- Hypoxic ischemic encephalopathy.
- Multiple congenital anomalies.
- Chromosomal abnormalities.
- Preterm less than 28 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 endocanSerum endocan will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life. | Diagnostic test | Group I, Group II |
| Serum copeptinSerum copeptin will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life. | Diagnostic test | Group I, Group II |
Primary outcome
Serum endocan level for prediction of severity of respiratory distress syndrome
Time frame: First day of life
Serum endocan level for prediction of severity of respiratory distress syndrome (RDS) will be recorded.
3 secondary outcomes
Serum copeptin level for prediction of severity of respiratory distress syndrome
Time frame: 5th day of life
Serum endocan level for prediction of mortality
Time frame: First day of life
Serum copeptin level for prediction of mortality
Time frame: 5th day of life
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 4 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Endocan
Not yet recruitingObservational study
Real World Positioning of Tyrosine Kinase Inhibitors (TKIs) Within Systemic Treatment Strategies for Advanced Neuroendocrine Tumors (NETs)
Well-Differentiated Neuroendocrine Tumors (NETs)
Not yet recruitingObservational study
Serum Endocan Levels in Colorectal Cancer
Colorectal Cancer
Not yet recruitingObservational study
Survival Without Persistent Limiting Toxicity: Real Life Prospective Cohort of Advanced Neuroendocrine Tumor
Neuroendocrine (NE) Tumors
Not yet recruitingObservational study
Prospective Observational Analysis of Circulating Endocan Levels in Patients Presenting With Acute Diverticulitis
Diverticulitis
Not yet recruitingObservational study
Effect of Non-surgical Periodontal Therapy in Hypertensive Patients With Assessment of Endocan and TNF-α Levels in GCF
Periodontitis, Hypertension
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?
An observational study of Endocan and Copeptin, run by Tanta 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. 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?
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 Asmaa M Elmesiry, MD (00201224285567, asmaa.elmesery@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum endocan level for prediction of severity of respiratory distress syndrome (time frame: First day of life). 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 4 Sep 2025.