Trial Outcomes & Findings for A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation (NCT NCT03181958)
NCT ID: NCT03181958
Last Updated: 2021-09-30
Results Overview
the total days of the baby supported with the ventilator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1493 participants
Primary outcome timeframe
up to 8 weeks
Results posted on
2021-09-30
Participant Flow
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.
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.
Participant milestones
| Measure |
NHFOV
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
497
|
501
|
495
|
|
Overall Study
COMPLETED
|
480
|
480
|
480
|
|
Overall Study
NOT COMPLETED
|
17
|
21
|
15
|
Reasons for withdrawal
| Measure |
NHFOV
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
21
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
Total
n=1440 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.4 weeks
STANDARD_DEVIATION 1.8 • n=480 Participants
|
29.5 weeks
STANDARD_DEVIATION 1.7 • n=480 Participants
|
29.4 weeks
STANDARD_DEVIATION 1.8 • n=480 Participants
|
29.4 weeks
STANDARD_DEVIATION 1.8 • n=1440 Participants
|
|
Sex: Female, Male
Female
|
296 Participants
n=480 Participants
|
208 Participants
n=480 Participants
|
292 Participants
n=480 Participants
|
796 Participants
n=1440 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=480 Participants
|
272 Participants
n=480 Participants
|
188 Participants
n=480 Participants
|
644 Participants
n=1440 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Birth Weight
|
1317 g
STANDARD_DEVIATION 353 • n=480 Participants
|
1334 g
STANDARD_DEVIATION 366 • n=480 Participants
|
1341 g
STANDARD_DEVIATION 318 • n=480 Participants
|
1337 g
STANDARD_DEVIATION 352 • n=1440 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksthe total days of the baby supported with the ventilator
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Duration of Invasive Mechanical Ventilation
|
6.3 day
Standard Deviation 6.0
|
7.8 day
Standard Deviation 7.2
|
7.3 day
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: up to 8 weeksnon-invasive ventilation was need after extubation
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Ventilator-free Days
|
34 day
Interval 17.0 to 52.0
|
32 day
Interval 20.0 to 45.0
|
35 day
Interval 21.0 to 52.0
|
PRIMARY outcome
Timeframe: up to 8 weeksthe total numbers of the baby supported with ventilator
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Babies With Reintubation
|
63 Participants
|
123 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksairleaks was diagnosed after extubation
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Airleaks
|
4 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: at gestational age of 36 weeks or at dischargeBronchopulmonary 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
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia(BPD)
|
163 Participants
|
184 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksRetinopathy of prematurity\> 2nd stage was diagnosed after extubation
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Retinopathy of Prematurity> 2nd Stage
|
63 Participants
|
74 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksNeonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage
|
33 Participants
|
24 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksIntraventricular hemorrhage\>2nd grade was diagnosed after extubation
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Intraventricular Hemorrhage>2nd Grade
|
48 Participants
|
63 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: up to 8 weekssteroids was used for chronic lung disease
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Number of Participants With Need for Postnatal Steroids
|
63 Participants
|
77 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksthe baby died in hospital
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
In-hospital Mortality
|
8 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksthe baby was dead or diagnosed with BPD.
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Composite Mortality/BPD
|
171 Participants
|
189 Participants
|
186 Participants
|
SECONDARY outcome
Timeframe: during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 monthWeekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Weekly Weight Gain
|
13.0 grams/day
Standard Deviation 5.3
|
12.1 grams/day
Standard Deviation 4.9
|
12.4 grams/day
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: up to 8 weekshemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols
Outcome measures
| Measure |
NHFOV
n=480 Participants
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 Participants
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 Participants
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Haemodynamically Significant Patent Ductus Arteriosus (PDA)
|
138 Participants
|
148 Participants
|
163 Participants
|
Adverse Events
NHFOV
Serious events: 0 serious events
Other events: 137 other events
Deaths: 8 deaths
NCPAP
Serious events: 0 serious events
Other events: 126 other events
Deaths: 5 deaths
NIPPV
Serious events: 0 serious events
Other events: 119 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NHFOV
n=480 participants at risk
neonates assigned to NHFOV will be started with the following boundaries:
a) 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.
NHFOV: Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
|
NCPAP
n=480 participants at risk
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.
NCPAP: Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
|
NIPPV
n=480 participants at risk
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).
NIPPV: Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Nasal skin injury
|
28.5%
137/480 • Number of events 137 • up to 8 weeks
Nasal skin injury
|
26.2%
126/480 • up to 8 weeks
Nasal skin injury
|
24.8%
119/480 • Number of events 119 • up to 8 weeks
Nasal skin injury
|
Additional Information
Dr.Yuan Shi
Children's Hospital of Chongqing Medical University
Phone: +86 23 68757731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place