ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development)

ASCEND（儿童 ARDS 和 ECMO 启动策略对神经发育的影响）

• 批准号: 10468145
• 负责人: Ryan Barbaro
• 金额: $ 62.3万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468145
• 关键词: Acute; Acute Respiratory Distress Syndrome; Address; Age; Anticoagulation; Blood; Brain; Breathing; Cannulas; Child; Child Support; Childhood; Clinical; Clinical Trials; Communication; Consequentialism; Critically ill children; Data; Data Collection; Data Element; Equipoise; Evaluation; Extracorporeal Membrane Oxygenation; Failure; Family; Fatigue; Funding; Guidelines; Hemorrhage; High-Frequency Ventilation; Impairment; Intervention; Knowledge; Lead; Life; Longitudinal prospective study; Measures; Mechanical Ventilators; Mechanical ventilation; Morbidity - disease rate; Motor; National Heart, Lung, and Blood Institute; Nervous System Trauma; Nutritional Support; Organ failure; Outcome; Outcome Study; Oxygen; Patient-Focused Outcomes; Pediatric Acute Respiratory Distress Syndrome; Positioning Attribute; Prone Position; Protocols documentation; Pump lung; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Registries; Sensory; Site; Stroke; Supination; Support Groups; Techniques; Testing; Uncertainty; Ventilator; Ventilator-induced lung injury; artificial lung; blood pump; comparative effectiveness study; conventional therapy; experience; functional outcomes; functional status; health related quality of life; instrument; mental state; mortality; neurodevelopment; preservation; prospective; respiratory; response; systematic review; treatment as usual; ventilation

Project Abstract Decades after extracorporeal membrane oxygenation (ECMO) was first used to support children with severe pediatric acute respiratory distress syndrome (PARDS), pediatric intensivists lack both prospective studies of long-term outcomes in ECMO for PARDS and well-powered studies comparing the impact of ECMO initiation strategies on mortality and morbidity. While clinicians lack the equipoise necessary to randomize ECMO in dying children, there is uncertainty on if and when it is best to initiate ECMO to preserve survival, functioning, and quality of life. To answer the question, if and when ECMO should be initiated in children with severe PARDS, it is necessary to compare the long-term outcomes in ECMO supported children to otherwise similar children who did not receive ECMO at the same threshold if at all. An opportunity to address this question is provided by NHLBI-funded Prone and Oscillation Pediatric Clinical Trial (PROSpect) and the ECMO registry, Extracorporeal Life Support Organization (ELSO). PROSpect is a randomized clinical trial testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in 1,000 children with severe PARDS. PROSpect manages subjects with a rigorous protocol that reserves ECMO for protocol failure. The ELSO Registry includes children receiving usual care ECMO, initiated at the discretion of the intensivist. ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development) will harmonize PROSpect and ELSO data collection and prospectively measure long-term functional status and quality of life in 550 children with severe PARDS from ELSO sites. ASCEND will then match children in both groups on their propensity to receive usual care ECMO. ASCEND combines real-world observational data (from ELSO) and a randomized clinical trial (from PROSpect) by matching similarly critically ill children treated under usual care ECMO or a rigorous ventilation protocol that reserves ECMO for protocol failure. Our specific aims include: Aim 1: We will test the hypotheses that one year after children receive usual care ECMO for PARDS, there will be a decline in long-term functional status and health-related quality of life as well as an increase in the proportion of children receiving respiratory support. Aim 2: We will test the hypotheses that 90-day mortality, one-year functional status, and one-year health- related quality of life are not equivalent for children with usual care ECMO (in ELSO) and PROSpect's protocolized therapies.

项目摘要 体外膜氧合（ECMO）几十年后首次用于支持严重的儿童 小儿急性呼吸窘迫综合征（PARS），儿科强化主义者缺乏对的前瞻性研究 ECMO的长期结局和供电的研究比较ECMO启动的影响 关于死亡率和发病率的策略。虽然临床医生缺乏将ECMO随机进行必要的设备 垂死的孩子，是否以及何时最好启动ECMO以保持生存，运作，运作， 和生活质量。要回答这个问题，是否以及何时在严重的儿童中发起ECMO PARDS，有必要将ECMO支持儿童的长期结果与其他类似的结果进行比较 如果有的话，没有在相同门槛上收到ECMO的孩子。 NHLBI资助的俯卧和振荡儿科临床的机会是解决这个问题的机会 试验（前景）和体外生命支持组织（ELSO）的ECMO注册表。前景是 随机临床试验测试仰卧/俯卧定位和常规机械的影响 1,000名儿童的短期和长期临床结局的通风/高频振荡通风 严重的帕克。 Prospect通过严格的协议管理受试者，该协议保留ECMO进行协议故障。 ELSO注册表包括受浓度主义者酌情发起的常规护理ECMO的儿童。 上升（儿童的ARDS和ECMO的启动策略对神经发展的影响）将协调 前景和ELSO数据收集以及前瞻性衡量的长期功能状况和生活质量 在550名来自ELSO站点的严重pard的儿童中。然后，上升将与他们的两组中的孩子相匹配 接受通常的护理ECMO的倾向。上升结合了现实世界的观察数据（来自ELSO）和A 通过与经常护理相似的患病儿童匹配，随机临床试验（来自前景） ECMO或严格的通风协议保留ECMO用于协议故障。我们的具体目的包括： 目的1：我们将测试孩子在儿童接受普通护理ecmo后一年的假设， 长期功能状况和与健康相关的生活质量的下降以及增加 接受呼吸支持的儿童比例。 AIM 2：我们将测试90天死亡率，一年功能状况和一年健康的假设 相关的生活质量对于患有ECMO的儿童（在ELSO中）和Prospect的儿童而言并不等于 方案疗法。