Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT07154134
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum endocan level for prediction of severity of respiratory distress syndrome', 'timeFrame': 'First day of life', 'description': 'Serum endocan level for prediction of severity of respiratory distress syndrome (RDS) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Serum copeptin level for prediction of severity of respiratory distress syndrome', 'timeFrame': '5th day of life', 'description': 'Serum copeptin level for the prediction of the severity of respiratory distress syndrome (RDS) will be recorded.'}, {'measure': 'Serum endocan level for prediction of mortality', 'timeFrame': 'First day of life', 'description': 'Serum endocan level for prediction of mortality will be recorded.'}, {'measure': 'Serum copeptin level for prediction of mortality', 'timeFrame': '5th day of life', 'description': 'Serum copeptin level for prediction of mortality will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endocan', 'Copeptin', 'Serum', 'Preterm Neonates', 'Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEndocan 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.\n\nCopeptin, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be conducted at the Neonatal Intensive Care Unit (NICU), Pediatric Department, Tanta University Hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prematurity.\n* Gestational age between 28 and 36 weeks.\n* Suffering from respiratory distress syndrome.\n\nExclusion Criteria:\n\n* Intrauterine growth restriction (IUGR).\n* Hypoxic ischemic encephalopathy.\n* Multiple congenital anomalies.\n* Chromosomal abnormalities.\n* Preterm less than 28 weeks.\n* Neonates with a maternal history of chorioamnionitis (early sepsis).\n* Infant of diabetic mother.\n* Prelabor rupture of membranes (PROM)\\> 2 hours.'}, 'identificationModule': {'nctId': 'NCT07154134', 'briefTitle': 'Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '36264PR1296/7/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Neonates with gestational ages between 28 and 34 gestational weeks.', 'interventionNames': ['Diagnostic Test: Serum endocan', 'Diagnostic Test: Serum copeptin']}, {'label': 'Group II', 'description': 'Neonates with gestational ages between 34 and 36 gestational weeks.', 'interventionNames': ['Diagnostic Test: Serum endocan', 'Diagnostic Test: Serum copeptin']}], 'interventions': [{'name': 'Serum endocan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum endocan will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Serum copeptin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum copeptin will be measured by an enzyme-linked immunosorbent assay (ELISA) on the first day of life.', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Asmaa M Elmesiry, MD', 'role': 'CONTACT', 'email': 'asmaa.elmesery@med.tanta.edu.eg', 'phone': '00201224285567'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Asmaa M Elmesiry, MD', 'role': 'CONTACT', 'email': 'asmaa.elmesery@med.tanta.edu.eg', 'phone': '00201224285567'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Asmaa Mahmoud Abdel Hamid Elmesiry', 'investigatorAffiliation': 'Tanta University'}}}}