Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01530360
Status:
COMPLETED
Last Update Posted:
2012-12-10
First Post:
2012-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-07', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-02-07', 'lastUpdatePostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of medical management elicited by cerebral oxygenation out of range', 'timeFrame': '0-72 hours of life', 'description': 'Recording of the type of change of management as defined by the treatment guideline'}], 'secondaryOutcomes': [{'measure': 'Adverse device effects', 'timeFrame': '0-72 hours', 'description': 'Expected and unexpected'}, {'measure': 'burden of hypo-and hyperoxia', 'timeFrame': '0-72 hours', 'description': 'measured as %hours out of the target range (55-85%)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Premature Infants', 'Near-infrared Spectroscopy', 'Oximetry']}, 'referencesModule': {'references': [{'pmid': '22006900', 'type': 'BACKGROUND', 'citation': 'Greisen G, Leung T, Wolf M. Has the time come to use near-infrared spectroscopy as a routine clinical tool in preterm infants undergoing intensive care? Philos Trans A Math Phys Eng Sci. 2011 Nov 28;369(1955):4440-51. doi: 10.1098/rsta.2011.0261.'}, {'pmid': '23340184', 'type': 'DERIVED', 'citation': 'Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Lemmers P, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Stoy LS, Wolf M, Greisen G. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Dan Med J. 2013 Jan;60(1):A4533.'}]}, 'descriptionModule': {'briefSummary': 'Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age at birth less than 28 completed weeks\n* cerebral oximeter in place at 3 hours after birth\n\nExclusion Criteria:\n\n* decision not to provide full life support'}, 'identificationModule': {'nctId': 'NCT01530360', 'acronym': 'SafeBoosC-p', 'briefTitle': 'Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Safeguarding the Brains of Our Smallest Children - a Pilot Study', 'orgStudyIdInfo': {'id': 'SBP010911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cerebral oximetry + treatment guideline', 'description': 'Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline', 'interventionNames': ['Device: cerebral oximeter']}], 'interventions': [{'name': 'cerebral oximeter', 'type': 'DEVICE', 'description': 'INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA', 'armGroupLabels': ['cerebral oximetry + treatment guideline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Neonatology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Gorm Greisen, MD,DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gorm Greisen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elsass Foundation', 'class': 'OTHER'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}, {'name': 'Medical University of Graz', 'class': 'OTHER'}, {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, {'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'University College Cork', 'class': 'OTHER'}, {'name': 'University of Zurich', 'class': 'OTHER'}, {'name': 'University of Milan', 'class': 'OTHER'}, {'name': 'Universitair Medisch Centrum Utrecht', 'class': 'UNKNOWN'}, {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor,head of department', 'investigatorFullName': 'Gorm Greisen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}