Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-26 @ 9:49 PM
Study NCT ID:
NCT01255618
Status:
UNKNOWN
Last Update Posted:
2010-12-07
First Post:
2010-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral oxygenation measurement', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Oxygenation', 'Peripheric Oxygenation', 'Polycythaemic Infants']}, 'descriptionModule': {'briefSummary': 'Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and hemodynamics, and changes in newborn period.The aim of the present study is to investigate cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange transfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '4 Hours', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants who admitted to neonatal intensive care unit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nterm (≥37wk) infants whom determined ≥ 65% haematocrit(Hct) levels\n\nExclusion Criteria:\n\nInfants with severe congenital malformation, sepsis, intracranial hemorrhage, birth asphyxia were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01255618', 'briefTitle': 'The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group, control group', 'interventionNames': ['Device: INVOS 5100']}], 'interventions': [{'name': 'INVOS 5100', 'type': 'DEVICE', 'description': 'Near-infrared range and has been used in newborn infants since 1985. Fibre-optic bundles or optodes are placed either on opposite sides of the tissue being interrogated (usually a limb or the head of a young baby) to measure transmitted light, or close together to measure reflected light. Light enters through one optode and a fraction of the photons is captured by a second optode and conveyed to the measuring device. NIRS uses a frequency band between 650 nm and 1000 nm and relies on three important phenomena: (1) human tissue is relatively transparent to light in the near-infrared region of the spectrum; (2) pigmented compounds known as chromophores absorb light as it passes through biological tissue; and (3) human tissues contain substances whose absorption spectra at near-infrared wavelengths are well defined and depend on their oxygenation status.', 'armGroupLabels': ['study group, control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06330', 'city': 'Ankara', 'state': 'Altındag', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'gonca sandal, M.D.', 'role': 'CONTACT', 'email': 'kocabasgonca@mynet.com', 'phone': '+90 505 487 10 27'}], 'facility': 'Zekai Tahir Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'ugur dilmen, proff', 'role': 'CONTACT', 'email': 'ugurdilmen@gmail.com', 'phone': '+90 312 506 5270'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zekai Tahir Burak Maternity Teaching Hospital', 'oldOrganization': 'Zekai Tahir Burak Maternity Teaching Hospital'}}}}