Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 9:59 AM
Study NCT ID:
NCT05141435
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NHFOV as Primary Support in Very Preterm Infants With RDS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shiyuan@hospital.cqmu.edu.cn', 'phone': '+86 15084335697', 'title': 'Prof. Shi Yuan', 'organization': "Children's Hospital of Chongqing Medical University"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 172, 'otherNumAffected': 0, 'seriousNumAtRisk': 172, 'deathsNumAffected': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 170, 'otherNumAffected': 0, 'seriousNumAtRisk': 170, 'deathsNumAffected': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 72 hrs from the beginning of the study mode', 'description': 'The respiratory support failure will be considered if one of the following occurs: (1) severe respiratory acidosis (defined as PaCO2 \\>60mm Hg with pH\\<7.2) for at least 1hour; (2) hypoxia refractory to study intervention (defined as SpO2 \\<90%, with FiO2=0.4 and maximal pressures allowed in the study arm) for at least 1 hour after the administration of surfactant; (3) severe apnoea (defined as recurrent apnoea with \\>3 episodes/hour associated with heart rate \\<100/min or a single episode of apnoea requiring bag and mask ventilation) and (4) attending physician determined that urgent intubation is necessary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'description': 'the diagnosis a Chest XR', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks of postmenstrual age', 'description': 'defined according to the NICHD definition', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Retinopathy of Prematurity (ROP)≥ 2nd Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Necrotizing Enterocolitis (NEC) ≥ 2nd Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Intraventricular Hemorrhage ≥ 3nd Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Thick Secretions Causing an Airway Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Nasal Trauma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Composite Mortality/BPD Tality/BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Weekly Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '6', 'groupId': 'OG000'}, {'value': '16', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'description': 'in grams/d', 'unitOfMeasure': 'g/Kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Duration of Non Invasive Respiratory Assistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '42'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Duration of Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '73'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years from birth', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'the Rate of Patent Doctus Arterious', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'OG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If a pharmaceutical or surgical treatment is required is considered. Small doctuses closing spontaneously during the first days of life are not included.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'FG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'From August, 2022, through August, 2024, a total of 20 centers screened 729 infants, of which 405 were eligible. We recruited 360 infants (180 in each group), to account for dropouts. Finally, 342 infants completed the trial (170 in NHFOV; 172 in NCPAP group.)', 'preAssignmentDetails': '45 Did not undergo randomization 25 Refused to participate 11 transferr out of the NICU before randomisation 9 major congenital malformations'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NCPAP', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'BG001', 'title': 'NHFOV', 'description': 'infants receive primary non-invasive respiratory support by mean of nCPAP: neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.\n\ninfants receive primary non-invasive respiratory support by mean of NHFOV: neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '1', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '970', 'spread': '212', 'groupId': 'BG000'}, {'value': '940', 'spread': '204', 'groupId': 'BG001'}, {'value': '950', 'spread': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '27.0', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '27.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-01', 'size': 272061, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-21T08:33', 'hasProtocol': True}, {'date': '2022-08-01', 'size': 150468, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-21T08:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2021-11-19', 'resultsFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-21', 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Bronchopulmonary Dysplasia', 'timeFrame': '36 weeks of postmenstrual age', 'description': 'defined according to the NICHD definition'}, {'measure': 'Rate of Retinopathy of Prematurity (ROP)≥ 2nd Stage', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Rate of Necrotizing Enterocolitis (NEC) ≥ 2nd Stage', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Rate of Intraventricular Hemorrhage ≥ 3nd Grade', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Rate of Thick Secretions Causing an Airway Obstruction', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Rate of Nasal Trauma', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Composite Mortality/BPD Tality/BPD', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Weekly Weight Gain', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'description': 'in grams/d'}, {'measure': 'Overall Duration of Non Invasive Respiratory Assistance', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first'}, {'measure': 'Overall Duration of Hospitalisation', 'timeFrame': 'up to 2 years from birth'}, {'measure': 'the Rate of Patent Doctus Arterious', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If a pharmaceutical or surgical treatment is required is considered. Small doctuses closing spontaneously during the first days of life are not included.'}], 'primaryOutcomes': [{'measure': 'Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation', 'timeFrame': 'within 72 hrs from the beginning of the study mode', 'description': 'The respiratory support failure will be considered if one of the following occurs: (1) severe respiratory acidosis (defined as PaCO2 \\>60mm Hg with pH\\<7.2) for at least 1hour; (2) hypoxia refractory to study intervention (defined as SpO2 \\<90%, with FiO2=0.4 and maximal pressures allowed in the study arm) for at least 1 hour after the administration of surfactant; (3) severe apnoea (defined as recurrent apnoea with \\>3 episodes/hour associated with heart rate \\<100/min or a single episode of apnoea requiring bag and mask ventilation) and (4) attending physician determined that urgent intubation is necessary.'}], 'secondaryOutcomes': [{'measure': 'Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support', 'timeFrame': 'the first 4weeks of life or until NICU discharge, whichever comes first', 'description': 'the diagnosis a Chest XR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal high frequency oscillation ventilation(NHFOV); nasal continuous positive airway pressure(NCPAP); preterm infants'], 'conditions': ['to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates']}, 'referencesModule': {'references': [{'pmid': '41052898', 'type': 'DERIVED', 'citation': 'Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y; NHFOV study group. Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial. BMJ. 2025 Oct 6;391:e085569. doi: 10.1136/bmj-2025-085569.'}, {'pmid': '36868587', 'type': 'DERIVED', 'citation': 'Li Y, Zhu X, Shi Y; Noninvasive High-Frequency Oscillatory Ventilation Study Group. Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in extremely preterm infants with respiratory distress syndrome: study protocol for a multicentre randomised controlled, superiority trial. BMJ Open. 2023 Mar 3;13(3):e068450. doi: 10.1136/bmjopen-2022-068450.'}]}, 'descriptionModule': {'briefSummary': 'This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (NIV) mode.', 'detailedDescription': 'Preterm infants are eligible to the study if they they match the following inclusion criteria: (1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%;; (3) Age less than 2 hours; (4)Informed parental consent has been obtained.\n\nNeonates will be randomized and assigned either to nCPAP or NHFOV arms with a 1:1ratio, when patients fulfill all inclusion criteria. Randomization cannot be done earlier. Simple randomization will be done according to a computer-generated random number table and will be posted in a specific secured website 24/7 available. Twins will be allocated in the same treatment group. Infants randomized to one arm cannot crossover to the other or vice- versa during the study. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 per target SpO2 89-94% after starting the respiratory support, newborns receive Surfactant by "LISA" technique, administration of surfactant (Curosurf,Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg.\n\nAfter the administration of surfactant, if FiO2 requirement is persistently \\>0.4 to keep SpO2 89-94% or severe apnea episodes are present (defined as recurrent apnea with \\>3 episodes/h associated with heart rate \\<100/min or a single episode of apnea requiring bag and mask ventilation within a 24-hour period ) or at the blood gas (arterial or free-flowing capillary blood) PaCO2\\>60 mmHg and potential of hydrogen (pH)\\<7.20 obtained at least 1 hour after commencement of the assigned treatment, newborns are intubated and mechanically ventilated.\n\nFor all the newborns enrolled in the study, arterial or free-flowing capillary blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Hours', 'minimumAge': '0 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%；（3） Age less than 2 hours\n\nExclusion Criteria:\n\n* Intubated forany reasons at birth\n\n * Major congenital malformations or known complex congenital heart disease\n * No parental consent'}, 'identificationModule': {'nctId': 'NCT05141435', 'briefTitle': 'NHFOV as Primary Support in Very Preterm Infants With RDS', 'organization': {'class': 'OTHER', 'fullName': "Jiulongpo No.1 People's Hospital"}, 'officialTitle': 'NHFOV vs nCPAP in Very Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial', 'orgStudyIdInfo': {'id': 'NHFOV prevent intubation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NCPAP', 'interventionNames': ['Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP', 'Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NHFOV', 'interventionNames': ['Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP', 'Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV']}], 'interventions': [{'name': 'infants receive primary non-invasive respiratory support by mean of nCPAP', 'type': 'PROCEDURE', 'description': 'neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.', 'armGroupLabels': ['NCPAP', 'NHFOV']}, {'name': 'infants receive primary non-invasive respiratory support by mean of NHFOV', 'type': 'PROCEDURE', 'description': 'neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).', 'armGroupLabels': ['NCPAP', 'NHFOV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Provincial Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'The Second Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qujing', 'state': 'Yunnan', 'country': 'China', 'facility': 'Qujing Maternity and cChild Healthcare Hospital', 'geoPoint': {'lat': 25.48333, 'lon': 103.78333}}], 'overallOfficials': [{'name': 'Yuan Shi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Chongqing Medical University"}]}, 'ipdSharingStatementModule': {'url': 'http://nasone.rxdemo.cn/admin/login/login', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Jiulongpo No.1 People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangxi Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, {'name': 'Guiyang Maternity and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region', 'class': 'OTHER'}, {'name': 'Hunan Provincial Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'Zhangzhou Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': "Women and Children's Health Hospital of Yulin", 'class': 'OTHER'}, {'name': 'Chongqing Three Gorges Central Hospital', 'class': 'OTHER'}, {'name': 'Gansu Provincial Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': "The First People's Hospital of Yunnan", 'class': 'OTHER'}, {'name': "Chengdu Women's and Children's Central Hospital", 'class': 'OTHER'}, {'name': "Maternal and Children's Healthcare Hospital of Taian", 'class': 'OTHER'}, {'name': "People's Hospital of Xinjiang Uygur Autonomous Region", 'class': 'OTHER'}, {'name': "Quanzhou Children's Hospital", 'class': 'OTHER'}, {'name': 'Chongqing West Hospital', 'class': 'OTHER'}, {'name': 'Chongqing Medical Center for Women and Children', 'class': 'OTHER'}, {'name': 'Xiamen Maternity & Child Care Hospital', 'class': 'OTHER'}, {'name': 'Qujing Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': 'Liuzhou Maternity and Child Healthcare Hospital', 'class': 'OTHER'}, {'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Xingwang Zhu', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}