Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 9:38 AM
Study NCT ID:
NCT03181958
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2017-05-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shiyuan@hospital.cqmu.edu.cn', 'phone': '+86 23 68757731', 'title': 'Dr.Yuan Shi', 'organization': "Children's Hospital of Chongqing Medical University"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 8 weeks', 'description': 'Nasal skin injury', 'eventGroups': [{'id': 'EG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 137, 'seriousNumAtRisk': 480, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 126, 'seriousNumAtRisk': 480, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.", 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 119, 'seriousNumAtRisk': 480, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 137, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 480, 'numAffected': 126}, {'groupId': 'EG002', 'numAtRisk': 480, 'numEvents': 119, 'numAffected': 119}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Invasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '9.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 8 weeks', 'description': 'the total days of the baby supported with the ventilator', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '52'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '45'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 8 weeks', 'description': 'non-invasive ventilation was need after extubation', 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Babies With Reintubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'the total numbers of the baby supported with ventilator', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Airleaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'airleaks was diagnosed after extubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bronchopulmonary Dysplasia(BPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at gestational age of 36 weeks or at discharge', 'description': 'Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Retinopathy of Prematurity> 2nd Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'Retinopathy of prematurity\\> 2nd stage was diagnosed after extubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'Neonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intraventricular Hemorrhage>2nd Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'Intraventricular hemorrhage\\>2nd grade was diagnosed after extubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Need for Postnatal Steroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'steroids was used for chronic lung disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'the baby died in hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite Mortality/BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'the baby was dead or diagnosed with BPD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weekly Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '6.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 month', 'description': 'Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'grams/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Haemodynamically Significant Patent Ductus Arteriosus (PDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '480', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'OG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 8 weeks', 'description': 'hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'FG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'FG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '497'}, {'groupId': 'FG001', 'numSubjects': '501'}, {'groupId': 'FG002', 'numSubjects': '495'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}, {'groupId': 'FG001', 'numSubjects': '480'}, {'groupId': 'FG002', 'numSubjects': '480'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Between December 2017 and May 2021, 1493 infants underwent randomization and data from 1440 were analyzed. A total of 53 infants were excluded from this analysis because missing data.', 'preAssignmentDetails': 'Between December 2017 and May 2021, 1493 infants underwent randomization and data from 1440 were analyzed. A total of 53 infants were excluded from this analysis because missing data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}, {'value': '1440', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.\n\nNHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.'}, {'id': 'BG001', 'title': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.\n\nNCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.'}, {'id': 'BG002', 'title': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).\n\nNIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}, {'value': '1440', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29.4', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '29.4', 'spread': '1.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}, {'value': '1440', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}, {'value': '796', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '644', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Birth Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '480', 'groupId': 'BG002'}, {'value': '1440', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1317', 'spread': '353', 'groupId': 'BG000'}, {'value': '1334', 'spread': '366', 'groupId': 'BG001'}, {'value': '1341', 'spread': '318', 'groupId': 'BG002'}, {'value': '1337', 'spread': '352', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-02', 'size': 256633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-02T04:55', 'hasProtocol': True}, {'date': '2021-09-02', 'size': 140874, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-02T04:55', 'hasProtocol': False}, {'date': '2021-09-02', 'size': 133961, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-02T04:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Blinding towards the caregivers is impossible and blinding towards the patients makes no sense. However, outcomes' assessors will be blinded, as endpoints will be recorded by investigators not involved in patients' care. An assessor per each participating NICU will be nominated. Moreover, investigators performing the final statistical analyses will be blinded to the treatment allocation, as data collected by assessors will be inserted in the dedicated website and the arms' allocation will be re-coded."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'When the neonate had fulfilled the extubation criteria, extubation will took place with a gentle intratracheal suction. Upper airways will then be suctioned and intervention will be started immediately as follows:\n\nVentilators\n\n* CPAP: CPAP will be provided by either variable flow or continuous flow devices, as there is no evidence that one type of CPAP generator would be better than any other.\n* NIPPV: NIPPV will be provided by any type of neonatal ventilator. Synchronization will not be applied, as many currently marketed neonatal ventilators usually do not provide it for NIPPV.\n* NHFOV: NHFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A). Other machines providing high frequency ventilations will not be used.\n\nImportantly, the randomization should be done within one hour from the extubation to avoid bias.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2017-05-28', 'resultsFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-02', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Invasive Mechanical Ventilation', 'timeFrame': 'up to 8 weeks', 'description': 'the total days of the baby supported with the ventilator'}, {'measure': 'Ventilator-free Days', 'timeFrame': 'up to 8 weeks', 'description': 'non-invasive ventilation was need after extubation'}, {'measure': 'Number of Babies With Reintubation', 'timeFrame': 'up to 8 weeks', 'description': 'the total numbers of the baby supported with ventilator'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Airleaks', 'timeFrame': 'up to 8 weeks', 'description': 'airleaks was diagnosed after extubation'}, {'measure': 'Number of Participants With Bronchopulmonary Dysplasia(BPD)', 'timeFrame': 'at gestational age of 36 weeks or at discharge', 'description': 'Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or'}, {'measure': 'Number of Participants With Retinopathy of Prematurity> 2nd Stage', 'timeFrame': 'up to 8 weeks', 'description': 'Retinopathy of prematurity\\> 2nd stage was diagnosed after extubation'}, {'measure': 'Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage', 'timeFrame': 'up to 8 weeks', 'description': 'Neonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation'}, {'measure': 'Number of Participants With Intraventricular Hemorrhage>2nd Grade', 'timeFrame': 'up to 8 weeks', 'description': 'Intraventricular hemorrhage\\>2nd grade was diagnosed after extubation'}, {'measure': 'Number of Participants With Need for Postnatal Steroids', 'timeFrame': 'up to 8 weeks', 'description': 'steroids was used for chronic lung disease'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'up to 8 weeks', 'description': 'the baby died in hospital'}, {'measure': 'Composite Mortality/BPD', 'timeFrame': 'up to 8 weeks', 'description': 'the baby was dead or diagnosed with BPD.'}, {'measure': 'Weekly Weight Gain', 'timeFrame': 'during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 month', 'description': 'Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Haemodynamically Significant Patent Ductus Arteriosus (PDA)', 'timeFrame': 'up to 8 weeks', 'description': 'hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal high frequency oscillation ventilation(NHFOV)', 'nasal continuous positive airway pressure(NCPAP)', 'nasal intermittent positive pressure ventilation（NIPPV）', 'neonatal respiratory distress syndrome(NRDS)', 'preterm infants'], 'conditions': ['Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies']}, 'referencesModule': {'references': [{'pmid': '37399009', 'type': 'DERIVED', 'citation': 'Zhu X, Li F, Shi Y, Feng Z, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Effectiveness of Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation vs Noninvasive High-Frequency Oscillatory Ventilation as Support After Extubation of Neonates Born Extremely Preterm or With More Severe Respiratory Failure: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2321644. doi: 10.1001/jamanetworkopen.2023.21644.'}, {'pmid': '35467744', 'type': 'DERIVED', 'citation': 'Zhu X, Qi H, Feng Z, Shi Y, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Noninvasive High-Frequency Oscillatory Ventilation vs Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation as Postextubation Support for Preterm Neonates in China: A Randomized Clinical Trial. JAMA Pediatr. 2022 Jun 1;176(6):551-559. doi: 10.1001/jamapediatrics.2022.0710.'}, {'pmid': '31349833', 'type': 'DERIVED', 'citation': 'Shi Y, De Luca D; NASal OscillatioN post-Extubation (NASONE) study group. Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to treat RDS, according to several recent trials,consists in providing continuous positive airway pressure (CPAP) from the first minutes of life using short binasal prongs or masks, followed by early selective surfactant administration for babies with worsening oxygenation and/or increasing work of breathing. Any effort should be done to minimize the time under invasive mechanical ventilation (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates fails this approach and eventually need IMV.The duration of IMV is a well known risk factor for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with significant morbidity and mortality.\n\nTo minimize the duration of IMV, various non invasive respiratory support modalities are available in neonatal intensive care units (NICU). CPAP is presently the most common technique used in this regard. However, a systematic review has shown that non-invasive positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main drawback is the lack of synchronization, which is difficult to be accurately achieved and is usually unavailable. A more recent alternative technique is non-invasive high frequency oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a continuous distending positive pressure with oscillations superimposed on spontaneous tidal breathing with no need for synchronization. The physiological, biological and clinical details about NHFOV have been described elsewhere.\n\nTo date, there is only one small observational uncontrolled study about the use of NHFOV after extubation in preterm infants. Other relatively small case series or retrospective cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not taking into account respiratory physiology.An European survey showed that, despite the absence of large randomized clinical trials, NHFOV is quite widely used, at least in some Countries and no major side effects are reported, although large data about NHFOV safety are lacking. This may be due to the relative NHFOV easiness of use but evidence-based and physiology-driven data are warranted about this technique.', 'detailedDescription': 'NHFOV should theoretically provide the advantages of invasive high frequency oscillatory ventilation (no need for synchronization, high efficiency in CO2 removal, less volume/barotrauma) and nasal CPAP (non-invasive interface, oxygenation improvement by the increase in functional residual capacity through alveolar recruitment). NHFOV should allow to increase mean airway pressure (Paw) avoiding gas trapping and hypercarbia, thanks to the superimposed high frequency oscillations. Therefore, NHFOV is more likely to be beneficial for those neonates requiring high distending pressure to open up their lungs, such as babies at high risk of extubation failure due to severity of their lung disease. This may also be the case of extremely preterm, BPD-developing neonates who have increased airway resistances, while they are subjected to a deranged alveolarization and lung growth. Neonates presenting with respiratory acidosis may also benefit from NHFOV. Several animal and bench studies investigated the physiology and peculiarities of NHFOV and these data should be used to conduct a physiology-guided trial in order to avoid errors done in the early trials about invasive high frequency ventilation.\n\nThis study will be the first large trial aiming to compare CPAP vs NIPPV vs NHFOV in preterm neonates after surfactant replacement and during their entire NICU stay, to reduce the total need of invasive ventilation. Since there is a lack of formal data regarding NHFOV safety, some safety outcomes will also be considered.Specific subgroup analysis will be conducted for pre-specified groups of patients who may most likely benefit from NHFOV, according to the above-described physiological characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '30 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age between 25+0 and 32+6 weeks;\n* birth weight more than 600 g;\n* supported with any type of endotracheal ventilation;\n* Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH\\>7.20 PaCO2\\<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw \\<=7-8 cmH2O; d. FiO2\\<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).;\n* Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.;\n\nExclusion Criteria:\n\n* major congenital anomalies or chromosomal abnormalities;\n* Presence of neuromuscular disease;\n* Upper respiratory tract abnormalities; ;\n* need for surgery known before the first extubation;\n* Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation\n* congenital lung diseases or malformations or pulmonary hypoplasia'}, 'identificationModule': {'nctId': 'NCT03181958', 'briefTitle': 'A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) vs Nasal Intermittent Positive Pressure Ventilation（NIPPV） as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NHFOV', 'description': 'neonates assigned to NHFOV will be started with the following boundaries:\n\na) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment, similar to what is done in endotracheal high frequency oscillatory ventilation targeting a FiO2≤25-30%. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90%-95%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-12Hz). c)Inspiratory time 50% (1:1).d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2o; amplitude will be titrated according to PaCO2.', 'interventionNames': ['Device: NHFOV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NCPAP', 'description': 'Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.', 'interventionNames': ['Device: NCPAP']}, {'type': 'EXPERIMENTAL', 'label': 'NIPPV', 'description': "neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).", 'interventionNames': ['Device: NIPPV']}], 'interventions': [{'name': 'NHFOV', 'type': 'DEVICE', 'description': 'Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.', 'armGroupLabels': ['NHFOV']}, {'name': 'NCPAP', 'type': 'DEVICE', 'description': 'Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.', 'armGroupLabels': ['NCPAP']}, {'name': 'NIPPV', 'type': 'DEVICE', 'description': 'Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.', 'armGroupLabels': ['NIPPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Shi Yuan, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'At Oct-22,2017,Suzhou,PR.China.', 'ipdSharing': 'YES', 'description': 'Every researchers can obtain the IPD after the study completely.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, {'name': "Jiulongpo No.1 People's Hospital", 'class': 'OTHER'}, {'name': 'Chongqing Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': "Children's Hospital of The Capital Institute of Pediatrics", 'class': 'OTHER'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'First Hospital of Tsinghua University', 'class': 'OTHER'}, {'name': "Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': "Quanzhou Children's Hospital", 'class': 'OTHER'}, {'name': 'Xiamen Maternity & Child Care Hospital', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Guangdong Academy of Medical Science and General Hospital', 'class': 'OTHER'}, {'name': 'Guangdong Women and Children Hospital', 'class': 'OTHER'}, {'name': "Women and Children's Health Hospital of Yulin", 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Guiyang Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': "Zunyi First People's Hospital", 'class': 'INDUSTRY'}, {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': 'Gansu Provincial Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': "Zhengzhou Children's Hospital, China", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'the Maternal and Child Health Hospital of Hainan Province', 'class': 'OTHER'}, {'name': 'Bethune International Peace Hospital', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "Children's Hospital of Nanjing Medical University", 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': "Maternal and Children's Healthcare Hospital of Taian", 'class': 'OTHER'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Shanxi Provincial Maternity and Children's Hospital", 'class': 'OTHER'}, {'name': "Chengdu Women and Children's Center Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital Of Southwest Medical University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Southwest Medical University', 'class': 'OTHER'}, {'name': "Shenzhen People's Hospital, The Second Medical College of Jinan University", 'class': 'OTHER'}, {'name': 'Tianjin Central Hospital of Gynecology Obstetrics', 'class': 'OTHER'}, {'name': "People's Hospital of Xinjiang Uygur Autonomous Region", 'class': 'OTHER'}, {'name': "Kunming Children's Hospital", 'class': 'OTHER'}, {'name': "The First People's Hospital of Yunnan", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': "Yan'an Affiliated Hospital of Kunming Medical University", 'class': 'OTHER'}, {'name': "Women and Children's Health Hospital of Qujing", 'class': 'OTHER'}, {'name': "The People's Hospital of Dehong Autonomous Prefecture", 'class': 'OTHER'}, {'name': "The First People's Hospital of Yinchuan", 'class': 'OTHER'}, {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, {'name': "Hunan Children's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Women and Children Hospital of Qinghai Province', 'class': 'OTHER'}, {'name': "Jiangxi Province Children's Hospital", 'class': 'OTHER'}, {'name': "Inner Mongolia People's Hospital", 'class': 'OTHER'}, {'name': 'Mianyang Central Hospital', 'class': 'OTHER'}, {'name': "People's Liberation Army No.202 Hospital", 'class': 'OTHER'}, {'name': "Ningbo Women & Children's Hospital", 'class': 'OTHER'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Qinhuangdao Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'Xuzhou Children Hospital', 'class': 'OTHER'}, {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': "Xianyang Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Ma Juan', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}