Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 7:47 AM
Study NCT ID:
NCT01362504
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2011-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-07', 'studyFirstSubmitDate': '2011-05-26', 'studyFirstSubmitQcDate': '2011-05-27', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pro-adrenomedullin', 'Neonatal sepsis', 'Prognosis', 'Sepsis marker', 'Clinical sepsis', 'Proven sepsis'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study. Eighty healthy matched neonates served as a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '24 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm and term neonates with sepsis were enrolled in this study including 80 cases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical sepsis and/or proven sepsis.\n\nExclusion Criteria:\n\n* Acute kidney injury\n* Intracranial hemorrhage (Grade III and IV)'}, 'identificationModule': {'nctId': 'NCT01362504', 'briefTitle': 'Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Zekai Tahir Burak Maternity Teaching Hospital Neonatal Intensive Care Unit', 'orgStudyIdInfo': {'id': 'ZTB0663'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical sepsis'}, {'label': 'Proven sepsis'}, {'label': 'Control group', 'description': 'healthy neonates'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06600', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'investigatorFullName': 'Mehmet Yekta', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}