A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
NCT ID: NCT03181958
Last Updated: 2021-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1493 participants
INTERVENTIONAL
2017-12-01
2021-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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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.
Interventions
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NHFOV
Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
NCPAP
Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
NIPPV
Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Minutes
1 Month
ALL
No
Sponsors
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Children's Hospital of Chongqing Medical University
OTHER
Jiulongpo No.1 People's Hospital
OTHER
Chongqing Maternal and Child Health Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Children's Hospital of The Capital Institute of Pediatrics
OTHER
Peking University Third Hospital
OTHER
First Hospital of Tsinghua University
OTHER
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Quanzhou Children's Hospital
OTHER
Xiamen Maternity & Child Care Hospital
OTHER
Zhujiang Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Guangdong Academy of Medical Science and General Hospital
OTHER
Guangdong Women and Children Hospital
OTHER
Women and Children's Health Hospital of Yulin
OTHER
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Guiyang Maternal and Child Health Care Hospital
OTHER
Zunyi First People's Hospital
INDUSTRY
Lanzhou University Second Hospital
OTHER
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
LanZhou University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Zhengzhou Children's Hospital, China
OTHER
Third Affiliated Hospital of Zhengzhou University
OTHER
the Maternal and Child Health Hospital of Hainan Province
OTHER
Bethune International Peace Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Children's Hospital of Nanjing Medical University
OTHER
The First Hospital of Jilin University
OTHER
Children's Hospital of Fudan University
OTHER
Maternal and Children's Healthcare Hospital of Taian
OTHER
The Second Hospital of Shandong University
OTHER
Shanxi Provincial Maternity and Children's Hospital
OTHER
Chengdu Women and Children's Center Hospital
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Affiliated Hospital of Southwest Medical University
OTHER
Shenzhen People's Hospital, The Second Medical College of Jinan University
OTHER
Tianjin Central Hospital of Gynecology Obstetrics
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Kunming Children's Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Women and Children's Health Hospital of Qujing
OTHER
The People's Hospital of Dehong Autonomous Prefecture
OTHER
The First People's Hospital of Yinchuan
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Beijing 302 Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Women and Children Hospital of Qinghai Province
OTHER
Jiangxi Province Children's Hospital
OTHER
Inner Mongolia People's Hospital
OTHER
Mianyang Central Hospital
OTHER
People's Liberation Army No.202 Hospital
OTHER
Ningbo Women & Children's Hospital
OTHER
Shanghai Children's Medical Center
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Nanjing Medical University
OTHER
Qinhuangdao Maternal and Child Health Care Hospital
OTHER
Xuzhou Children Hospital
OTHER
Catholic University of the Sacred Heart
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Xianyang Children's Hospital
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
Responsible Party
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Ma Juan
director
Principal Investigators
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Shi Yuan, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Locations
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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201721
Identifier Type: -
Identifier Source: org_study_id
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