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

2/2 膈肌启动通气辅助 (DIVA) 试验

• 批准号: 10479806
• 负责人: Sarah J Ratcliffe
• 金额: $ 42.63万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-03 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10479806
• 关键词: Address; Alveolar; Biometry; Bronchopulmonary Dysplasia; Case Report Form; Chest wall structure; Childhood; Chronic lung disease; Clinical Trials; Collaborations; Continuous Positive Airway Pressure; Cost Savings; Data; Data Coordinating Center; Data Security; Development; Documentation; Ensure; Exposure to; FAIR principles; FDA approved; Failure; Familiarity; Funding; Gestational Age; Goals; Health Care Costs; Hour; Human; Incidence; Infant; Injury; Intermittent Positive-Pressure Ventilation; Intubation; Lung; Mechanical ventilation; Meta-Analysis; Methodology; Methods; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nose; Outcome; Oxygen; Phase; Phase III Clinical Trials; Physiological; Positioning Attribute; Pregnancy; Premature Birth; Premature Infant; Quality Control; Randomized, Controlled Trials; Reproducibility of Results; Research; Research Design; Respiratory Diaphragm; Respiratory Failure; Security; Statistical Data Interpretation; Technology; Testing; Tidal Volume; United States; United States National Institutes of Health; Ventilator-induced lung injury; clinical research site; clinically relevant; data infrastructure; data integration; data management; data sharing; data structure; evidence base; extreme prematurity; improved; long-term sequelae; neural; neurotransmission; novel; operation; patient population; premature; pressure; prevent; quality assurance; randomized trial; recruit; respiratory; ventilation; years of life lost

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.

概括 慢性肺病和早产并发症是影响儿科寿命的主要原因 迷失在美国。支气管肺发育不良（BPD）是一种慢性肺部疾病，是支气管肺发育不良最常见的后遗症。 早产，是儿童发病的主要原因。仅在美国 BPD 每年的医疗费用超过 24 亿美元。呼吸机引起的肺损伤（VILI）是公认的 也是 BPD 的重要贡献者。接触氧气和正压通气可促进发育 未成熟早产肺的停滞和实质损伤。因此，肺部保护策略优先考虑非 有创呼吸支持治疗呼吸衰竭的早产儿，但无创呼吸支持的失败率 呼吸支持（即：持续气道正压通气 [CPAP]）较高。在鼻试验的荟萃分析中 无创间歇性正压通气（NIPPV），同步 NIPPV 显着降低 与 CPAP 相比，BPD 的发生率更高。非同步 NIPPV 未见此益处。 然而，当前的标准同步方法不可靠并且不能提供一致的 同步。神经调节通气辅助 (NAVA) 是 FDA 批准的技术，是一种新颖的方法 将无创支持 (NIV) 与婴儿呼吸驱动同步。这种有效的非侵入性 同步与膈肌电活动相匹配，以提供同步且准确的潮气量 与神经信号成正比。在这些集群化的 UG3/UH3 和 U24 应用中，我们提出了一种实用的、 在 358 名妊娠 240/7-276/7 周的早产儿中进行的非盲 III 期随机对照试验 (RCT) 呼吸衰竭确定 NIV-NAVA 与非同步鼻间歇性阳性相比 压力通气 (NIPPV) 将减少拔管后 5 天内拔管失败的发生率 机械通气。