2/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

摘要 慢性肺部疾病和早产并发症是导致长寿的主要儿科因素 迷失在美国。支气管肺发育不良(BPD)是一种慢性肺部疾病，是最常见的 早产儿，是导致儿童发病率的主要呼吸道原因。仅在美国，每桶石油日产量 每年的医疗成本超过24亿美元。呼吸机诱导的肺损伤(VILI)是公认的 也是BPD的重要贡献者。暴露在氧气和正压通风下会导致发育 未成熟早产肺的停搏和实质损伤。因此，肺保护策略优先考虑非 有创呼吸支持治疗早产儿呼吸衰竭，但无创性失败率 呼吸支持(即：持续气道正压[CPAP])较高。鼻腔给药试验的Meta分析 无创间歇正压通气(NIPPV)、同步NIPPV显著降低 BPD发生率与CPAP比较。这种好处在非同步NIPPV中看不到。 然而，当前的标准同步手段是不可靠的，并且不能提供一致的 同步。神经调节辅助呼吸机(NAVA)是美国食品和药物管理局批准的一项新技术 将无创支持(NIV)与婴儿呼吸驱动同步进行。这种有效的非侵入性 同步与电隔膜活动相匹配，以提供同步和准确的潮气量 与神经信号的比例。在这些集群UG3/UH3和U24应用中，我们提出了一种实用的、 358例早产儿240/7-276/7周的非盲法III期随机对照试验 呼吸衰竭判定是否NIV-NAVA与非同步化鼻腔间歇阳性比较 压力通风(NIPPV)，将减少拔管后5天内拔管失败的发生率 机械通风。

SUMMARY Chronic lung disease and complications from preterm birth are the leading pediatric contributors to years of life lost in the USA. Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common sequela of prematurity and is the leading respiratory cause of childhood morbidity. In the United States alone BPD accounts for over $2.4 billion in healthcare costs annually. Ventilator induced lung injury (VILI) is an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Lung protective strategies therefore prioritize non- invasive respiratory support for preterm infants with respiratory failure, but failure rates of non-invasive respiratory support (ie: continuous positive airway pressure [CPAP]) are high. In meta-analysis of trials of nasal non-invasive intermittent positive pressure ventilation (NIPPV), synchronized NIPPV significantly reduced the incidence of BPD when compared with CPAP. This benefit was not seen with non-synchronized NIPPV. However, current standard means of synchronization are unreliable and do not deliver consistent synchronization. Neurally Adjusted Ventilatory Assist (NAVA), an FDA approved technology, is a novel method to synchronize non-invasive support (NIV) with infant respiratory drive. This effective non-invasive synchronization matches electrical diaphragmatic activity to deliver synchronized and accurate tidal volumes in proportion to the neural signal. In these clustered UG3/UH3 and U24 applications, we propose a pragmatic, unblinded, Phase III, randomized controlled trial (RCT) in 358 preterm infants 240/7-276/7 weeks gestation in respiratory failure to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NIPPV), will reduce the incidence of extubation failure within 5 days of extubation from mechanical ventilation.