Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome

NCT07154134 | Recruiting

• 1 other identifier: 36264PR1296/7/25
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endocan; Copeptin; Serum; Preterm Neonates; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  First day of life

Secondary Outcomes (3)

• Serum copeptin level for prediction of severity of respiratory distress syndrome

  5th day of life

• Serum endocan level for prediction of mortality

  First day of life

• Serum copeptin level for prediction of mortality

  5th day of life

Study Arms (2)

Group I

Neonates with gestational ages between 28 and 34 gestational weeks.

Diagnostic Test: Serum endocan; Diagnostic Test: Serum copeptin

Group II

Neonates with gestational ages between 34 and 36 gestational weeks.

Diagnostic Test: Serum endocan; Diagnostic Test: Serum copeptin

Interventions

Serum endocan DIAGNOSTIC_TEST

Serum endocan will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.

Group I; Group II

Serum copeptin DIAGNOSTIC_TEST

Serum copeptin will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.

Group I; Group II

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will be conducted at the Neonatal Intensive Care Unit (NICU), Pediatric Department, Tanta University Hospitals.

You may qualify if:

• Prematurity.
• Gestational age between 28 and 36 weeks.
• Suffering from respiratory distress syndrome.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Asmaa M Elmesiry, MD

CONTACT

00201224285567; asmaa.elmesery@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: July 10, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)