Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-14 @ 2:25 PM
Study NCT ID:
NCT02083705
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chest Compression and Sustained Inflation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'georg.schmoelzer@me.com', 'phone': '7807354647', 'title': 'Georg Schmölzer', 'organization': 'University of Alberta'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'within 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'SI+CC', 'description': 'Chest compression will be superimposed by sustained inflations during CPR:\n\n"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.\n\nCC+SI: Chest compression will be superimposed by sustained inflation during CPR', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '3:1 CPR', 'description': 'CPR using 3:1 C:V ratio:\n\n"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.\n\n3:1 CPR: CPR using 3:1 ratio (control group)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Air leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraventricular haemorrhage all grades', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraventricular haemorrhage grade >3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Needed to Achieve Return of Spontaneous Circulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SI+CC', 'description': 'Chest compression will be superimposed by sustained inflations during CPR:\n\n"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.\n\nCC+SI: Chest compression will be superimposed by sustained inflation during CPR'}, {'id': 'OG001', 'title': '3:1 CPR', 'description': 'CPR using 3:1 C:V ratio:\n\n"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.\n\n3:1 CPR: CPR using 3:1 ratio (control group)'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '9', 'groupId': 'OG000'}, {'value': '138', 'spread': '72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \\<33 weeks of gestation.\n\nFor this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'within the first 10 minutes after birth', 'description': 'We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SI+CC', 'description': 'Chest compression will be superimposed by sustained inflations during CPR:\n\n"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.\n\nCC+SI: Chest compression will be superimposed by sustained inflation during CPR'}, {'id': 'FG001', 'title': '3:1 CPR', 'description': 'CPR using 3:1 C:V ratio:\n\n"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.\n\n3:1 CPR: CPR using 3:1 ratio (control group)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SI+CC', 'description': 'Chest compression will be superimposed by sustained inflations during CPR:\n\n"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.\n\nCC+SI: Chest compression will be superimposed by sustained inflation during CPR'}, {'id': 'BG001', 'title': '3:1 CPR', 'description': 'CPR using 3:1 C:V ratio:\n\n"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.\n\n3:1 CPR: CPR using 3:1 ratio (control group)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2014-01-13', 'resultsFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-22', 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Needed to Achieve Return of Spontaneous Circulation', 'timeFrame': 'within the first 10 minutes after birth', 'description': 'We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chest compression, Delivery Room, NICU,'], 'conditions': ['Newborn Infants Having Asystole or Bradycardia at Birth']}, 'referencesModule': {'references': [{'pmid': '28988159', 'type': 'DERIVED', 'citation': 'Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewborn infants with asystole Newborn infants with bradycardia\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02083705', 'briefTitle': 'Chest Compression and Sustained Inflation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants', 'orgStudyIdInfo': {'id': 'Pro00034524_CC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SI+CC', 'description': 'Chest compression will be superimposed by sustained inflations during CPR:\n\n"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.', 'interventionNames': ['Procedure: CC+SI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3:1 CPR', 'description': 'CPR using 3:1 C:V ratio:\n\n"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.', 'interventionNames': ['Procedure: 3:1 CPR']}], 'interventions': [{'name': 'CC+SI', 'type': 'PROCEDURE', 'description': 'Chest compression will be superimposed by sustained inflation during CPR', 'armGroupLabels': ['SI+CC']}, {'name': '3:1 CPR', 'type': 'PROCEDURE', 'description': 'CPR using 3:1 ratio (control group)', 'armGroupLabels': ['3:1 CPR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Georg Schmolzer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}