1/2 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

1/2 膈肌启动通气辅助 (DIVA) 试验

• 批准号: 10214861
• 负责人: Sherry Courtney
• 金额: $ 41.6万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10214861
• 关键词: Age; Air; Alveolar; Birth; Bronchopulmonary Dysplasia; Cessation of life; Chest wall structure; Childhood; Chronic lung disease; Clinical; Complication; Continuous Positive Airway Pressure; Data; Development; Etiology; Exposure to; FDA approved; Failure; Gastrointestinal Hemorrhage; Gestational Age; Health Care Costs; Hour; Incidence; Infant; Injury; Intermittent Positive-Pressure Ventilation; Intubation; Lung; Mechanical ventilation; Meta-Analysis; Methods; Modeling; Morbidity - disease rate; Neurologic; Nose; Outcome; Oxygen; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Physiological; Population; Premature Birth; Premature Infant; Prevention; Randomized Clinical Trials; Randomized Controlled Trials; Respiratory Diaphragm; Respiratory Failure; Role; Site; Technology; Testing; Tidal Volume; Time; United States; Ventilator; Ventilator-induced lung injury; clinically relevant; family burden; gastrointestinal perforation; health care service utilization; improved; murine nodule inducing virus; nCPAP Ventilation; neurotransmission; novel; premature; pressure; prevent; recruit; relating to nervous system; respiratory; safety outcomes; trial design; ventilation; years of life lost

PROJECT SUMMARY Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. BPD results in a significant burden to families and increased health care utilization. In the United States alone BPD accounts for over $2.4 billion in healthcare costs annually. Ventilator induced lung injury (VILI) 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. Because even brief exposure to positive pressure ventilation is injurious, avoiding invasive intubated mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy. Lung protective strategies prioritize non-invasive respiratory support for preterm infants with respiratory failure, but failure rates of continuous positive airway pressure (CPAP) therapy are high. In meta-analysis of available trials, both synchronized and non-synchronized non-invasive positive pressure ventilation (NIPPV) are superior to CPAP for preventing extubation failure in preterm infants. A stronger effect size was observed for synchronized NIPPV vs. CPAP than for non-synchronized NIPPV vs. CPAP. However, until recently no FDA-approved reliable methods to provide synchronized NIPPV for preterm infants were available in the US Neurally Adjusted Ventilatory Assist (NAVA), an FDA approved technology, is a novel method to synchronize ventilatory support 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. To date, the clinical impact of non-invasive NAVA (NIV-NAVA) on clinical outcomes in preterm infants has not been established. In these clustered UG3/UH3 and U24 applications, we propose a pragmatic, unblinded, phase III clinical trial in 478 extremely preterm infants of 24 0/7- 27 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized NIPPV, prevents extubation failure within 5 days of extubation from mechanical ventilation.

项目总结 支气管肺发育不良(Bpd)是早产儿最常见的并发症，也是 儿童发病的呼吸道原因。BPD给家庭带来了沉重的负担，并增加了健康 护理利用情况。仅在美国，BPD每年的医疗成本就超过24亿美元。 呼吸机诱导的肺损伤(VILI)是公认的BPD的重要因素.暴露在氧气中 正压通气可导致幼鼠发育停滞和实质损伤 早产肺。因为即使是短暂暴露在正压通风中也是有害的，避免有创 插管机械通气是目前公认的预防VILI和远期VILI的有效策略 BPD的后遗症。因此，使用呼吸机的时间和拔管成功率是重要的终点。 心理治疗。 肺保护策略优先于早产儿呼吸系统疾病的无创呼吸支持 失败，但持续正压(CPAP)治疗的失败率很高。在荟萃分析中 可用的试验，包括同步和非同步无创正压通气(NIPPV) 在预防早产儿拔管失败方面优于CPAP。观察到更强的效应大小 对于同步的NIPPV和CPAP，而不是非同步的NIPPV和CPAP。然而，直到最近，没有 FDA批准的为早产儿提供同步NIPPV的可靠方法在美国可用 美国食品和药物管理局批准的神经调节辅助呼吸机(NAVA)是一种新的治疗方法 使呼吸机支持与婴儿呼吸驱动同步。这种有效的非侵入性同步 匹配电隔膜活动，以按比例提供同步和准确的潮气量 神经信号。到目前为止，非侵入性NAVA(NIV-NAVA)对 早产儿尚未确诊。在这些群集化的UG3/UH3和U24应用中，我们建议 478例24.0/7-27.6/7周极早产儿的实用、非盲法III期临床试验 确定NIV-NAVA与非同步NIPPV相比是否能在5分钟内防止拔管失败的年龄 机械通气机拔管天数。