Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 1:39 AM
Study NCT ID:
NCT04439968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Brain Oxygenation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002534', 'term': 'Hypoxia, Brain'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Burden of Cerebral hypoxia or hyperoxia', 'timeFrame': 'From birth until first 7 days of life', 'description': 'Burden of cerebral hypoxia or hyperoxia from NIRS measures'}], 'primaryOutcomes': [{'measure': 'Neurodevelopmental outcome', 'timeFrame': '22-26 months of age', 'description': 'Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': 'from birth until hospital discharge, an average of 3 months.', 'description': 'Death prior to hospital discharge'}, {'measure': 'Retinopathy of prematurity', 'timeFrame': 'from birth until hospital discharge, an average of 3 months.', 'description': 'Occurrence of retinopathy of prematurity prior to hospital discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Hypoxia']}, 'descriptionModule': {'briefSummary': 'Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks\n* Less than 6 hours of age\n\nExclusion Criteria:\n\n* Skin integrity insufficient to allow placement of NIRS sensors\n* Decision not to provide full intensive care support\n* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment'}, 'identificationModule': {'nctId': 'NCT04439968', 'acronym': 'BOX', 'briefTitle': 'Neonatal Brain Oxygenation Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Targeted Cerebral Saturations in Extremely Preterm Infants', 'orgStudyIdInfo': {'id': '56759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted Csats', 'description': 'Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.', 'interventionNames': ['Other: Clinical algorithm']}, {'type': 'NO_INTERVENTION', 'label': 'Non-targeted Csats', 'description': 'Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.'}], 'interventions': [{'name': 'Clinical algorithm', 'type': 'OTHER', 'description': 'In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.', 'armGroupLabels': ['Targeted Csats']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Valerie Chock, M.D., M.S. Epi', 'investigatorAffiliation': 'Stanford University'}}}}