Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02698020
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-11', 'releaseDate': '2022-11-01'}, {'resetDate': '2025-04-15', 'releaseDate': '2025-03-27'}], 'estimatedResultsFirstSubmitDate': '2022-11-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018496', 'term': 'Hyperoxia'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcutaneous and blood-gas pO2', 'timeFrame': '30 min', 'description': 'Area under curve (AUC) and absolute values of pO2'}], 'secondaryOutcomes': [{'measure': 'Cerebral Oximetry', 'timeFrame': '30 min', 'description': 'AUC of O2 saturation'}, {'measure': 'Atelectasis', 'timeFrame': '30 min', 'description': 'Reduced lung compliance as a measure of atelectasis formation'}, {'measure': 'Isoprostane', 'timeFrame': '4 h', 'description': 'Level of isoprostanes in blood and urine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Newborn', 'Anesthesia', 'Oxygen', 'Hyperoxia'], 'conditions': ['Oxygen Toxicity', 'Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.', 'detailedDescription': 'Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Newborn less than 44 weeks postconceptional age\n2. No pulmonary disease, no oxygen requirement, or assisted ventilation\n3. No genetic syndrome'}, 'identificationModule': {'nctId': 'NCT02698020', 'acronym': 'ANOXneo', 'briefTitle': 'Optimized Oxygen Delivery During General Anesthesia in Newborn Infants', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.', 'orgStudyIdInfo': {'id': 'ANOXneo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'High level of supplemental inspired oxygen'}, {'type': 'EXPERIMENTAL', 'label': 'Room-air', 'description': 'Supplemental oxygen only provided if oxygen saturation below target', 'interventionNames': ['Procedure: Room-air']}], 'interventions': [{'name': 'Room-air', 'type': 'PROCEDURE', 'description': 'Provision of room-air', 'armGroupLabels': ['Room-air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital, Pediatric anesthesia Unit', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Johan Agren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Women's and Children's Health, Uppsala University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-01', 'type': 'RELEASE'}, {'date': '2023-09-11', 'type': 'RESET'}, {'date': '2025-03-27', 'type': 'RELEASE'}, {'date': '2025-04-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Uppsala University'}}}}