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

1/2 膈肌启动通气辅助 (DIVA) 试验

基本信息

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
项目类别：
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

项目摘要

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.

项目概要支气管肺发育不良（BPD）是早产儿最常见的并发症，也是最主要的并发症儿童发病的呼吸道原因。 BPD 给家庭带来重大负担并增加健康护理利用。仅在美国，BPD 每年就造成超过 24 亿美元的医疗费用。呼吸机引起的肺损伤 (VILI) 是 BPD 的一个公认的重要因素。暴露于氧气正压通气会导致未成熟儿童发育停滞和实质损伤早产肺。因为即使短暂暴露于正压通气也是有害的，因此避免侵入性通气插管机械通气是最广泛认可的预防 VILI 和长期并发症的策略 BPD 的后遗症。因此，使用呼吸机的时间和成功拔管率是重要的终点指标。治疗。肺保护策略优先考虑对患有呼吸系统疾病的早产儿进行无创呼吸支持失败，但持续气道正压通气 (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。观察到更强的效应量同步 NIPPV 与 CPAP 对比非同步 NIPPV 与 CPAP 对比。然而，直到最近还没有美国有 FDA 批准的可靠方法为早产儿提供同步 NIPPV 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通气支持与婴儿呼吸驱动同步。这种有效的非侵入性同步匹配膈肌电活动，以按比例提供同步且准确的潮气量神经信号。迄今为止，非侵入性 NAVA (NIV-NAVA) 对临床结果的临床影响早产儿尚未建立。在这些集群化的 UG3/UH3 和 U24 应用中，我们提出了对 478 名妊娠 24 0/7- 27 6/7 周的极早产儿进行的务实、非盲式 III 期临床试验年龄以确定 NIV-NAVA 与非同步 NIPPV 相比是否可以在 5 年内防止拔管失败从机械通气拔管的天数。