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A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation

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研究单位： [1]Daping Hospital and the Research Institute of Surgery of the Third Military Medical University [2]Children's Hospital of Chongqing Medical University [3]Jiulongpo No.1 People's Hospital [4]Chongqing Maternal and Child Health Hospital [5]The First Affiliated Hospital of Anhui Medical University [6]Children's Hospital of The Capital Institute of Pediatrics [7]Peking University Third Hospital [8]First Hospital of Tsinghua University [9]Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital [10]First Affiliated Hospital of Chongqing Medical University [11]Quanzhou Children's Hospital [12]Xiamen Maternity & Child Care Hospital [13]Zhujiang Hospital [14]Nanfang Hospital of Southern Medical University [15]Guangdong Academy of Medical Science and General Hospital [16]Guangdong Women and Children Hospital [17]Women and Children's Health Hospital of Yulin [18]Women and Children Health Care Hospitalof GuangXi Zhuang Autonomous [19]Second Affiliated Hospital of Guangzhou Medical University [20]Guiyang Maternal and Child Health Care Hospital [21]Zunyi First People's Hospital [22]Second Hospital of Lanzhou University [23]Gansu Provincial Maternity and Child-Care Hospital [24]LanZhou University [25]First Affiliated Hospital of Harbin Medical University [26]First Affiliated Hospital of Xinjiang Medical University [27]Zhengzhou Children's Hospital, China [28]Third Affiliated Hospital of Zhengzhou University [29]the Maternal and Child Health Hospital of Hainan Province [30]Bethune International Peace Hospital [31]Wuhan Union Hospital, China [32]Children's Hospital of Nanjing Medical University [33]The First Hospital of Jilin University [34]Children's Hospital of Fudan University [35]Maternal and Children's Healthcare Hospital of Taian [36]The Second Hospital of Shandong University [37]Shanxi Provincial Maternity and Children's Hospital [38]Chengdu Women and Children's Center Hospital [39]The Affiliated Hospital Of Southwest Medical University [40]Affiliated Hospital of Southwest Medical University [41]Shenzhen People's Hospital, The Second Medical College of Jinan University [42]Tianjin Central Hospital of Gynecology Obstetrics [43]People's Hospital of Xinjiang Uygur Autonomous Region [44]Kunming Children's Hospital [45]The First People's Hospital of Yunnan [46]First Affiliated Hospital of Kunming Medical University [47]Yan'an Affiliated Hospital of Kunming Medical University [48]Women and Children's Health Hospital of Qujing [49]The People's Hospital of Dehong Autonomous Prefecture [50]Yinchuan No 1 people's Hospital Affiliated of Ningxia Medical University [51]The Children's Hospital of Zhejiang University School of Medicine [52]Women's Hospital School Of Medicine Zhejiang University [53]Beijing 302 Hospital [54]Hunan Children's Hospital [55]Women and Children Hospital of Qinghai Province [56]Jiangxi Province Children's Hospital [57]Inner Mongolia People's Hospital [58]Mianyang Central Hospital [59]People's Liberation Army No.202 Hospital [60]Ningbo Women & Children's Hospital [61]Shanghai Children's Medical Center [62]First Affiliated Hospital of Guangxi Medical University [63]+T33 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University,Chongqing,Chongqing,China,400042

关键词： 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

研究目的：

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.