Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-03-11 @ 3:45 AM
Study NCT ID:
NCT02392806
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noah.hillman@health.slu.edu', 'phone': '3145779292', 'title': 'Noah Hillman', 'organization': 'Saint Louis University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bubble CPAP- BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device\n\nBubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bubble CPAP - B&B Bubbler, B&B Medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device\n\nBubble CPAP- B\\&B Bubbler, B\\&B Medical devices: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Extubation Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bubble CPAP- BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device\n\nBubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}, {'id': 'OG001', 'title': 'Bubble CPAP - B&B Bubbler, B&B Medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device\n\nBubble CPAP- B\\&B Bubbler, B\\&B Medical devices: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 72 hours of extubation', 'description': 'Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bubble CPAP- BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device\n\nBubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}, {'id': 'OG001', 'title': 'Bubble CPAP - B&B Bubbler, B&B Medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device\n\nBubble CPAP- B\\&B Bubbler, B\\&B Medical devices: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '96 hours', 'description': 'Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bubble CPAP- BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device\n\nBubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}, {'id': 'FG001', 'title': 'Bubble CPAP - B&B Bubbler, B&B Medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device\n\nBubble CPAP- B\\&B Bubbler, B\\&B Medical devices: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bubble CPAP- BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device\n\nBubble CPAP- BabiPlus, Respiralogics: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}, {'id': 'BG001', 'title': 'Bubble CPAP - B&B Bubbler, B&B Medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device\n\nBubble CPAP- B\\&B Bubbler, B\\&B Medical devices: Infant will be randomized to BabiPlus verses B\\&B Bubbler at time of extubation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '25.7', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks Gestational Age', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2015-02-27', 'resultsFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-30', 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Extubation Failure', 'timeFrame': 'Within 72 hours of extubation', 'description': 'Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation'}], 'secondaryOutcomes': [{'measure': 'Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly', 'timeFrame': '96 hours', 'description': 'Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Continuous positive airway pressure', 'CPAP', 'Bubble CPAP', 'Extubation failure', 'Preterm infant'], 'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B\\&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.', 'detailedDescription': "Primary outcome: Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation Secondary outcome: Number of infants that reach 21% inspired oxygen during initial study period Secondary outcome: Apnea/bradycardia events in the initial study period Secondary outcome: Mean oxygen requirement following initial study period\n\nPopulation: Infants born at \\<=1250 grams birth weight but \\>= 500 grams birth weight\n\nRandomization: Equal allocation stratified by gestational age (\\<27 weeks, \\>=27 weeks)\n\nStudy diagram:\n\n72h 24h X----------\\>X1-----------\\>Y2 Y----------\\>Y1-----------\\>X2 Infants will be randomly assigned to treatment X (BabiPlus, control group) or treatment Y (B\\&B Bubbler, intervention group). The primary outcome is bubble CPAP failure during the first 72 hours following extubation, measured at time point 1 in the diagram. Bubble CPAP failure is defined as requiring re-intubation or non-invasive positive pressure ventilation (NIPPV), requiring FiO2 of \\>60% for one hour or a pCO2 measurement of \\>65 mm Hg. For those infants that remain on CPAP during the initial study period, the number that reach 21% inspired oxygen for \\>12 consecutive hours will be compared between groups. This difference will also be analyzed using a Chi square test.\n\nThose infants that remain on CPAP following the 72 hour initial study period (e.g., did not meet primary outcome criteria) will be crossed over to the opposite treatment arm for at least 24 hours. The minimum oxygen requirement required to keep the saturations in the ordered range, per standard NICU guidelines, will be recorded and compared between time points 1 and 2.\n\nThis study design is complex due to the nature of the disease of these patients. Each day every infant's premature pulmonary disease is evolving. There is no way to control for this."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '100 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infant delivered at \\>=500 grams and \\<=1250 grams birth weight.\n2. Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.\n3. Infant has received exogenous surfactant during mechanical ventilation.\n\nExclusion Criteria:\n\n1. Decision by attending physician to redirect to comfort care\n2. Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)\n3. Birth weight \\>1250 grams or \\<500 grams.\n4. Non-English speaking parents. -'}, 'identificationModule': {'nctId': 'NCT02392806', 'briefTitle': 'Comparative Effectiveness Study of Bubble CPAP Devices in the NICU', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'Comparative Effectiveness Study of Bubble CPAP Devices in the NICU', 'orgStudyIdInfo': {'id': 'SLU Protocol # 24949'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BabiPlus, Respiralogics', 'description': 'Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\\&B Bubbler device for 24 hours', 'interventionNames': ['Device: Bubble CPAP- BabiPlus, Respiralogics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B&B Bubbler, B&B medical Technologies', 'description': 'Infants randomized to the B\\&B Bubbler device will be extubated to B\\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device for 24 hours', 'interventionNames': ['Device: Bubble CPAP- B&B Bubbler, B&B Medical devices']}], 'interventions': [{'name': 'Bubble CPAP- BabiPlus, Respiralogics', 'type': 'DEVICE', 'otherNames': ['Bubble Continuous Positive Airway Pressure (BCPAP)'], 'description': 'Infant will be randomized to BabiPlus Bubbler at time of extubation', 'armGroupLabels': ['BabiPlus, Respiralogics']}, {'name': 'Bubble CPAP- B&B Bubbler, B&B Medical devices', 'type': 'DEVICE', 'description': 'Infant will be randomized to B\\&B Bubbler at time of extubation', 'armGroupLabels': ['B&B Bubbler, B&B medical Technologies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Cardinal Glennon Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Noah H Hillman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Director, Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marya Strand, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Pediatrics', 'investigatorFullName': 'Marya Strand, MD', 'investigatorAffiliation': 'St. Louis University'}}}}