A Trial Comparing Noninvasive Ventilation Strategies in P... | NCT03181958

NCT03181958

Status Module

Sponsor/Collaborators Module

Name	Class
Children's Hospital of Chongqing Medical University	OTHER
Jiulongpo No.1 People's Hospital	OTHER
Chongqing Maternal and Child Health Hospital	OTHER

Oversight Module

Description Module

Brief Summary

Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to treat RDS, according to several recent trials,consists in providing continuous positive airway pressure (CPAP) from the first minutes of life using short binasal prongs or masks, followed by early selective surfactant administration for babies with worsening oxygenation and/or increasing work of breathing. Any effort should be done to minimize the time under invasive mechanical ventilation (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates fails this approach and eventually need IMV.The duration of IMV is a well known risk factor for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with significant morbidity and mortality.

To minimize the duration of IMV, various non invasive respiratory support modalities are available in neonatal intensive care units (NICU). CPAP is presently the most common technique used in this regard. However, a systematic review has shown that non-invasive positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main drawback is the lack of synchronization, which is difficult to be accurately achieved and is usually unavailable. A more recent alternative technique is non-invasive high frequency oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a continuous distending positive pressure with oscillations superimposed on spontaneous tidal breathing with no need for synchronization. The physiological, biological and clinical details about NHFOV have been described elsewhere.

To date, there is only one small observational uncontrolled study about the use of NHFOV after extubation in preterm infants. Other relatively small case series or retrospective cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not taking into account respiratory physiology.An European survey showed that, despite the absence of large randomized clinical trials, NHFOV is quite widely used, at least in some Countries and no major side effects are reported, although large data about NHFOV safety are lacking. This may be due to the relative NHFOV easiness of use but evidence-based and physiology-driven data are warranted about this technique.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NHFOV	Experimental	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.	Device: NHFOV
NCPAP	Active Comparator	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.	Device: NCPAP
NIPPV	Experimental	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).

Name	Type	Description	Arm Group Labels	Other Names
NHFOV	Device	Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.	NHFOV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of Invasive Mechanical Ventilation	the total days of the baby supported with the ventilator	up to 8 weeks
Ventilator-free Days	non-invasive ventilation was need after extubation	up to 8 weeks
Number of Babies With Reintubation	the total numbers of the baby supported with ventilator	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Airleaks	airleaks was diagnosed after extubation	up to 8 weeks
Number of Participants With Bronchopulmonary Dysplasia(BPD)	Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Shi Yuan, PhD,MD	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University		Chongqing	Chongqing Municipality	400042	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37399009	Derived	Zhu X, Li F, Shi Y, Feng Z, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Effectiveness of Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation vs Noninvasive High-Frequency Oscillatory Ventilation as Support After Extubation of Neonates Born Extremely Preterm or With More Severe Respiratory Failure: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2321644. doi: 10.1001/jamanetworkopen.2023.21644.
35467744

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 2, 2021	Sep 2, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

weeks

Title	Denominators	Categories
	ParticipantsBG000480 ParticipantsBG001480 ParticipantsBG002480 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000480 ParticipantsBG001480 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Birth Weight

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000480 ParticipantsBG001480 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Duration of Invasive Mechanical Ventilation

the total days of the baby supported with the ventilator

Posted

Mean

Standard Deviation

day

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG000480 OG001480 OG002480

Title

Denominators

Categories

Title	Measurements
	OG0006.3± 6.0 OG0017.8± 7.2 OG0027.3± 9.2

Primary

Ventilator-free Days

non-invasive ventilation was need after extubation

Posted

Median

Inter-Quartile Range

day

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Primary

Number of Babies With Reintubation

the total numbers of the baby supported with ventilator

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Secondary

Number of Participants With Airleaks

airleaks was diagnosed after extubation

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Secondary

Number of Participants With Bronchopulmonary Dysplasia(BPD)

Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or

Posted

Count of Participants

Participants

at gestational age of 36 weeks or at discharge

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Retinopathy of Prematurity> 2nd Stage

Retinopathy of prematurity> 2nd stage was diagnosed after extubation

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage

Neonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Number of Participants With Intraventricular Hemorrhage>2nd Grade

Intraventricular hemorrhage>2nd grade was diagnosed after extubation

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Number of Participants With Need for Postnatal Steroids

steroids was used for chronic lung disease

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Secondary

In-hospital Mortality

the baby died in hospital

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Secondary

Composite Mortality/BPD

the baby was dead or diagnosed with BPD.

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.
OG002	NIPPV

Secondary

Weekly Weight Gain

Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first

Posted

Mean

Standard Deviation

grams/day

during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 month

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Haemodynamically Significant Patent Ductus Arteriosus (PDA)

hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols

Posted

Count of Participants

Participants

up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	8	480	480	137	480
EG001	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.	5	480	480	126	480
EG002	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.	4	480	480	119	480

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasal skin injury	Injury, poisoning and procedural complications		Systematic Assessment		EG000137 events137 affected480 at risk EG001126 affected480 at risk EG002119 events119 affected480 at risk

ID	Term
D012127	Respiratory Distress Syndrome, Newborn

Ancestor Terms

ID	Term
D012128	Respiratory Distress Syndrome
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ParticipantsBG0031440