Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT01496027
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2011-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-09', 'studyFirstSubmitDate': '2011-12-10', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)', 'timeFrame': '6 hours', 'description': 'There are two FDA-approved near infrared cerebral oximeters:\n\n1. FORE-SIGHT- which uses laser light\n2. INVOS 5100- which uses light emmiting diode.\n\nMeasurements in adult patients have showed that FORE-SIGHT provides more stable signal. Purpose of our study is to compare these two devices in newborn patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral oxygenation', 'NIRS', 'tissue oximeters', 'near infrared spectroscopy', 'newborn'], 'conditions': ['Cerebral Oxygenation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'MacLeod D; Ikeda K; Vacchiano C Simultaneous Comparison of FORE-SIGHT and INVOS Cerebral Oximeters to Jugular Bulb and Arterial Co-Oximetry Measurements in Healthy Volunteers ANESTH ANALG 2009; 108(SCA Suppl);1-104'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinically stable, spontaneously breathing newborns will be included in the study. Enrolled patients will be divided into two groups: 15 term (≥37 weeks GA) and 15 preterm (32-37 weeks GA) newborns. NIRS measurements will be performed on the 1st and 3rd day of life.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically stable\n* Spontaneously breathing newborns\n\nExclusion Criteria:\n\n* Congenital heart defects or anomalies of central nervous system\n* Prematurity below 32 GA\n* Respiratory distress'}, 'identificationModule': {'nctId': 'NCT01496027', 'briefTitle': 'Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters', 'orgStudyIdInfo': {'id': '04515'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'term newborns'}, {'label': 'Preterm Newborns (32-37 GA)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-535', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Katedra Neonatologii', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Tomasz Szczapa', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}