Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-31 @ 4:23 AM
Study NCT ID:
NCT01251068
Status:
UNKNOWN
Last Update Posted:
2010-12-07
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-11-30', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral and peripheric oxygenation measurements in anemic preterm infants.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion'], 'conditions': ['Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion']}, 'descriptionModule': {'briefSummary': 'Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: \\<32 gestational age and/or \\<1500gr.,\\>30th day preterm infants -\n\nExclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01251068', 'briefTitle': 'Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gest age, cerebral ,somatic oxygenation measurement', 'interventionNames': ['Device: near infrared spectroscopy: invos 5100', 'Device: INVOS 5100', 'Device: near infrared spectroscopy device']}], 'interventions': [{'name': 'near infrared spectroscopy: invos 5100', 'type': 'DEVICE', 'description': 'duration:six hours', 'armGroupLabels': ['gest age, cerebral ,somatic oxygenation measurement']}, {'name': 'INVOS 5100', 'type': 'DEVICE', 'description': 'NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.', 'armGroupLabels': ['gest age, cerebral ,somatic oxygenation measurement']}, {'name': 'near infrared spectroscopy device', 'type': 'DEVICE', 'description': 'NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.', 'armGroupLabels': ['gest age, cerebral ,somatic oxygenation measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06330', 'city': 'Ankara', 'state': 'Hamamönü', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'gonca sandal, MD', 'role': 'CONTACT', 'email': 'kocabasgonca@mynet.com', 'phone': '+905054871028'}, {'name': 'gonca sandal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06330', 'city': 'Ankara', 'state': 'Hamamönü', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'UGUR, DILMEN', 'role': 'CONTACT', 'email': 'ugurdilmen@gmail.com', 'phone': '+903125065270'}, {'name': 'gonca sandal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'gonca sandal, MD', 'role': 'CONTACT', 'email': 'kocabasgonca@mynet.com', 'phone': '05054871028'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'oldOrganization': 'Neonatal Intensive Care Unit'}}}}