Back to resultsA Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Primary Purpose
Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NHFOV
NCPAP
NIPPV
Sponsored by
About this trial
This is an interventional treatment trial for Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies focused on measuring nasal high frequency oscillation ventilation(NHFOV), nasal continuous positive airway pressure(NCPAP), nasal intermittent positive pressure ventilation（NIPPV）, neonatal respiratory distress syndrome(NRDS), preterm infants
Eligibility Criteria
Inclusion Criteria:
- gestational age between 25+0 and 32+6 weeks;
- birth weight more than 600 g;
- supported with any type of endotracheal ventilation;
- Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH>7.20 PaCO2<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw <=7-8 cmH2O; d. FiO2<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).;
- Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.;
Exclusion Criteria:
- major congenital anomalies or chromosomal abnormalities;
- Presence of neuromuscular disease;
- Upper respiratory tract abnormalities; ;
- need for surgery known before the first extubation;
- Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation
- congenital lung diseases or malformations or pulmonary hypoplasia
Sites / Locations
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
NHFOV
NCPAP
NIPPV
Arm Description
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.
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.
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).
Outcomes
Primary Outcome Measures
Duration of Invasive Mechanical Ventilation
the total days of the baby supported with the ventilator
Ventilator-free Days
non-invasive ventilation was need after extubation
Number of Babies With Reintubation
the total numbers of the baby supported with ventilator
Secondary Outcome Measures
Number of Participants With Airleaks
airleaks was diagnosed after extubation
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
Number of Participants With Retinopathy of Prematurity> 2nd Stage
Retinopathy of prematurity> 2nd stage was diagnosed after extubation
Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage
Neonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation
Number of Participants With Intraventricular Hemorrhage>2nd Grade
Intraventricular hemorrhage>2nd grade was diagnosed after extubation
Number of Participants With Need for Postnatal Steroids
steroids was used for chronic lung disease
In-hospital Mortality
the baby died in hospital
Composite Mortality/BPD
the baby was dead or diagnosed with BPD.
Weekly Weight Gain
Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first
Haemodynamically Significant Patent Ductus Arteriosus (PDA)
hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols
Full Information
NCT ID
NCT03181958
First Posted
May 28, 2017
Last Updated
September 2, 2021
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Children's Hospital of Chongqing Medical University, Jiulongpo No.1 People's Hospital, Chongqing Maternal and Child Health Hospital, The First Affiliated Hospital of Anhui Medical University, Children's Hospital of The Capital Institute of Pediatrics, Peking University Third Hospital, First Hospital of Tsinghua University, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Chongqing Medical University, Quanzhou Children's Hospital, Xiamen Maternity & Child Care Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Women and Children's Health Hospital of Yulin, Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous, Second Affiliated Hospital of Guangzhou Medical University, Guiyang Maternal and Child Health Care Hospital, Zunyi First People's Hospital, Second Hospital of Lanzhou University, Gansu Provincial Maternal and Child Health Care Hospital, LanZhou University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Zhengzhou Children's Hospital, China, Third Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, Bethune International Peace Hospital, Wuhan Union Hospital, China, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Children's Hospital of Fudan University, Maternal and Children's Healthcare Hospital of Taian, The Second Hospital of Shandong University, Shanxi Provincial Maternity and Children's Hospital, Chengdu Women and Children's Center Hospital, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen People's Hospital, The Second Medical College of Jinan University, Tianjin Central Hospital of Gynecology Obstetrics, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming Children's Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Women and Children's Health Hospital of Qujing, The People's Hospital of Dehong Autonomous Prefecture, Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University, The Children's Hospital of Zhejiang University School of Medicine, Women's Hospital School Of Medicine Zhejiang University, Beijing 302 Hospital, Hunan Children's Hospital, Women and Children Hospital of Qinghai Province, Jiangxi Province Children's Hospital, Inner Mongolia People's Hospital, Mianyang Central Hospital, People's Liberation Army No.202 Hospital, Ningbo Women & Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Nanjing Medical University, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital, South Paris University Hospitals, Catholic University of the Sacred Heart, The First Affiliated Hospital of Zhengzhou University, Xianyang Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03181958
Brief Title
A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Official Title
Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) vs Nasal Intermittent Positive Pressure Ventilation（NIPPV） as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Children's Hospital of Chongqing Medical University, Jiulongpo No.1 People's Hospital, Chongqing Maternal and Child Health Hospital, The First Affiliated Hospital of Anhui Medical University, Children's Hospital of The Capital Institute of Pediatrics, Peking University Third Hospital, First Hospital of Tsinghua University, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Chongqing Medical University, Quanzhou Children's Hospital, Xiamen Maternity & Child Care Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Women and Children's Health Hospital of Yulin, Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous, Second Affiliated Hospital of Guangzhou Medical University, Guiyang Maternal and Child Health Care Hospital, Zunyi First People's Hospital, Second Hospital of Lanzhou University, Gansu Provincial Maternal and Child Health Care Hospital, LanZhou University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Zhengzhou Children's Hospital, China, Third Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, Bethune International Peace Hospital, Wuhan Union Hospital, China, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Children's Hospital of Fudan University, Maternal and Children's Healthcare Hospital of Taian, The Second Hospital of Shandong University, Shanxi Provincial Maternity and Children's Hospital, Chengdu Women and Children's Center Hospital, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen People's Hospital, The Second Medical College of Jinan University, Tianjin Central Hospital of Gynecology Obstetrics, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming Children's Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Women and Children's Health Hospital of Qujing, The People's Hospital of Dehong Autonomous Prefecture, Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University, The Children's Hospital of Zhejiang University School of Medicine, Women's Hospital School Of Medicine Zhejiang University, Beijing 302 Hospital, Hunan Children's Hospital, Women and Children Hospital of Qinghai Province, Jiangxi Province Children's Hospital, Inner Mongolia People's Hospital, Mianyang Central Hospital, People's Liberation Army No.202 Hospital, Ningbo Women & Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Nanjing Medical University, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital, South Paris University Hospitals, Catholic University of the Sacred Heart, The First Affiliated Hospital of Zhengzhou University, Xianyang Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
NHFOV should theoretically provide the advantages of invasive high frequency oscillatory ventilation (no need for synchronization, high efficiency in CO2 removal, less volume/barotrauma) and nasal CPAP (non-invasive interface, oxygenation improvement by the increase in functional residual capacity through alveolar recruitment). NHFOV should allow to increase mean airway pressure (Paw) avoiding gas trapping and hypercarbia, thanks to the superimposed high frequency oscillations. Therefore, NHFOV is more likely to be beneficial for those neonates requiring high distending pressure to open up their lungs, such as babies at high risk of extubation failure due to severity of their lung disease. This may also be the case of extremely preterm, BPD-developing neonates who have increased airway resistances, while they are subjected to a deranged alveolarization and lung growth. Neonates presenting with respiratory acidosis may also benefit from NHFOV. Several animal and bench studies investigated the physiology and peculiarities of NHFOV and these data should be used to conduct a physiology-guided trial in order to avoid errors done in the early trials about invasive high frequency ventilation.
This study will be the first large trial aiming to compare CPAP vs NIPPV vs NHFOV in preterm neonates after surfactant replacement and during their entire NICU stay, to reduce the total need of invasive ventilation. Since there is a lack of formal data regarding NHFOV safety, some safety outcomes will also be considered.Specific subgroup analysis will be conducted for pre-specified groups of patients who may most likely benefit from NHFOV, according to the above-described physiological characteristics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies
Keywords
nasal high frequency oscillation ventilation(NHFOV), nasal continuous positive airway pressure(NCPAP), nasal intermittent positive pressure ventilation（NIPPV）, neonatal respiratory distress syndrome(NRDS), preterm infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
When the neonate had fulfilled the extubation criteria, extubation will took place with a gentle intratracheal suction. Upper airways will then be suctioned and intervention will be started immediately as follows:
Ventilators
CPAP: CPAP will be provided by either variable flow or continuous flow devices, as there is no evidence that one type of CPAP generator would be better than any other.
NIPPV: NIPPV will be provided by any type of neonatal ventilator. Synchronization will not be applied, as many currently marketed neonatal ventilators usually do not provide it for NIPPV.
NHFOV: NHFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A). Other machines providing high frequency ventilations will not be used.
Importantly, the randomization should be done within one hour from the extubation to avoid bias.
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinding towards the caregivers is impossible and blinding towards the patients makes no sense. However, outcomes' assessors will be blinded, as endpoints will be recorded by investigators not involved in patients' care. An assessor per each participating NICU will be nominated. Moreover, investigators performing the final statistical analyses will be blinded to the treatment allocation, as data collected by assessors will be inserted in the dedicated website and the arms' allocation will be re-coded.
Allocation
Randomized
Enrollment
1493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NHFOV
Arm Type
Experimental
Arm Description
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.
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
Neonates assigned to the CPAP group were initiated on a pressure of 5 cmH2O. CPAP can be raised in steps of 1 cmH2O up to 8 cmH2O. If this is not enough to maintain SpO2 between 90% and 95%, FiO2 will be added up to 0.40.
Arm Title
NIPPV
Arm Type
Experimental
Arm Description
neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of 15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec(according to clinicians' evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at 30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).
Intervention Type
Device
Intervention Name(s)
NHFOV
Intervention Description
Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
Primary Outcome Measure Information:
Title
Duration of Invasive Mechanical Ventilation
Description
the total days of the baby supported with the ventilator
Time Frame
up to 8 weeks
Title
Ventilator-free Days
Description
non-invasive ventilation was need after extubation
Time Frame
up to 8 weeks
Title
Number of Babies With Reintubation
Description
the total numbers of the baby supported with ventilator
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Airleaks
Description
airleaks was diagnosed after extubation
Time Frame
up to 8 weeks
Title
Number of Participants With Bronchopulmonary Dysplasia(BPD)
Description
Bronchopulmonary dysplasia was defined, according to National Institutes of Health (NIH) criteria, by the receipt of any form of positive-airway-pressure support or a requirement for supplemental oxygen at 36 weeks. A requirement for supplemental oxygen at 36 weeks was defined as an FiO2 of 0.30 or more or
Time Frame
at gestational age of 36 weeks or at discharge
Title
Number of Participants With Retinopathy of Prematurity> 2nd Stage
Description
Retinopathy of prematurity> 2nd stage was diagnosed after extubation
Time Frame
up to 8 weeks
Title
Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage
Description
Neonatal necrotizing enterocolitis≥ 2nd stage was diagnosed after extubation
Time Frame
up to 8 weeks
Title
Number of Participants With Intraventricular Hemorrhage>2nd Grade
Description
Intraventricular hemorrhage>2nd grade was diagnosed after extubation
Time Frame
up to 8 weeks
Title
Number of Participants With Need for Postnatal Steroids
Description
steroids was used for chronic lung disease
Time Frame
up to 8 weeks
Title
In-hospital Mortality
Description
the baby died in hospital
Time Frame
up to 8 weeks
Title
Composite Mortality/BPD
Description
the baby was dead or diagnosed with BPD.
Time Frame
up to 8 weeks
Title
Weekly Weight Gain
Description
Weekly weight gain (in grams/day) for the first 4 weeks of life or until NICU discharge, whichever comes first
Time Frame
during hospitalization for the first 4 weeks of life or until NICU discharge whichever came first, an average of 1 month
Title
Haemodynamically Significant Patent Ductus Arteriosus (PDA)
Description
hemodynamically significant patent ductus arteriosus (PDA), defined according to local NICU protocols
Time Frame
up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age between 25+0 and 32+6 weeks;
birth weight more than 600 g;
supported with any type of endotracheal ventilation;
Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH>7.20 PaCO2<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw <=7-8 cmH2O; d. FiO2<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).;
Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.;
Exclusion Criteria:
major congenital anomalies or chromosomal abnormalities;
Presence of neuromuscular disease;
Upper respiratory tract abnormalities; ;
need for surgery known before the first extubation;
Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation
congenital lung diseases or malformations or pulmonary hypoplasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Every researchers can obtain the IPD after the study completely.
IPD Sharing Time Frame
At Oct-22,2017,Suzhou,PR.China.
Citations:
PubMed Identifier
35467744
Citation
Zhu X, Qi H, Feng Z, Shi Y, De Luca D; Nasal Oscillation Post-Extubation (NASONE) Study Group. Noninvasive High-Frequency Oscillatory Ventilation vs Nasal Continuous Positive Airway Pressure vs Nasal Intermittent Positive Pressure Ventilation as Postextubation Support for Preterm Neonates in China: A Randomized Clinical Trial. JAMA Pediatr. 2022 Jun 1;176(6):551-559. doi: 10.1001/jamapediatrics.2022.0710.
Results Reference
derived
PubMed Identifier
31349833
Citation
Shi Y, De Luca D; NASal OscillatioN post-Extubation (NASONE) study group. Continuous positive airway pressure (CPAP) vs noninvasive positive pressure ventilation (NIPPV) vs noninvasive high frequency oscillation ventilation (NHFOV) as post-extubation support in preterm neonates: protocol for an assessor-blinded, multicenter, randomized controlled trial. BMC Pediatr. 2019 Jul 26;19(1):256. doi: 10.1186/s12887-019-1625-1.
Results Reference
derived
Learn more about this trial
A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
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