2/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (DCC)

2/2 PROSpect：俯卧和摆动儿科临床试验 (DCC)

• 批准号: 10219345
• 负责人: DAVID WYPIJ
• 金额: $ 63.12万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10219345
• 关键词: Adherence; Adult Respiratory Distress Syndrome; Back; Biometry; Boston; Cannulations; Cardiac Surgery procedures; Cardiology; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Critical Care; Critical Illness; Critically ill children; Data; Data Coordinating Center; Decision Making; Eligibility Determination; Enrollment; Extracorporeal Membrane Oxygenation; Frequencies; Futility; High-Frequency Ventilation; Hospitals; Hour; Human Resources; Hypercapnia; Hypoxia; Inferior; Intention; International; Intervention; Intratracheal Intubation; Length of Stay; Life; Lung diseases; Mechanical ventilation; Methodology; Mission; Modernization; Monitor; National Heart, Lung, and Blood Institute; Outcome; Paper; Patient-Focused Outcomes; Patients; Pediatric Acute Respiratory Distress Syndrome; Pediatric Hospitals; Pediatric Intensive Care Units; Probability; Procedures; Process; Prone Position; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Research Personnel; Safety; Statistical Data Interpretation; Strategic Planning; Supination; Update; Ventilator; Work; age group; archive data; clinical practice; data archive; data management; experience; follow-up; functional status; health related quality of life; improved; lung injury; meetings; patient safety; performance site; primary outcome; response; risk benefit ratio; ventilation

Project Summary Although pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year, little evidence supports best ventilation practices. For 25 years, pediatric critical care clinicians have debated the risk-benefit ratio of supine versus prone positioning and conventional mechanical ventilation (CMV) versus high-frequency oscillatory ventilation (HFOV). The purpose of the proposed clinical trial PROSpect (PRone and OScillation PEdiatric Clinical Trial) is to provide evidence to support best ventilation practices in critically ill children with severe PARDS. The proposed study is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and CMV/HFOV in 45 pediatric intensive care units (PICUs; 30 U.S., 15 international) with at least 5 years of experience with these interventions. Up to 1000 patients with severe PARDS will be randomized to one of four groups (supine/CMV; prone/CMV; supine/HFOV; prone/HFOV), stratified by age group (<1; 1-7; 8- 17 years) and direct/indirect lung injury. Response adaptive randomization will begin after 400 patients provide complete data on the primary outcome, ventilator-free days. Any group demonstrating inferiority at pre-planned randomization update analyses will be eliminated to increase allocation to the remaining groups. PROSpect will close enrollment when any one group demonstrates superiority or for futility in answering the research question. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol received. In conjunction with the Clinical Coordinating Center, the PROSpect Data Coordinating Center (DCC) will achieve the launch, execution and completion of the proposed trial by accomplishing these specific aims (SA): SA1: To provide state-of-the-art data management and data monitoring processes for U.S. and international enrollment for PROSpect, for post-discharge follow-up and for eventual data archiving. SA2: To monitor study enrollment and progress, site performance, protocol adherence and patient safety in support of study coordination and Data and Safety Monitoring Board (DSMB) needs. SA3: To perform randomization update analyses to aid in decision-making regarding response adaptive randomization as well as interim analyses for review of outcomes and safety data for DSMB reports. SA4: To provide high-quality statistical analyses for primary and secondary study papers using modern statistical methodology and graphical procedures and to assist with the rapid dissemination of findings. This clinical trial will provide the definitive evidence necessary for the field to consider a major change in clinical practice in the care of critically ill children with severe PARDS.

项目摘要 小儿急性呼吸窘迫综合征（PARDS）是一种常见的、危及生命的疾病 每年都有成千上万的儿童经历这种情况，但很少有证据支持最佳通风做法。了25 多年来，儿科重症监护临床医生一直在争论仰卧位与俯卧位的风险效益比 和常规机械通气（CMV）与高频振荡通气（HFOV）。 拟定临床试验前景（PRone和振荡儿科临床试验）的目的是 提供证据支持重症PARDS患儿的最佳通气实践。拟议 研究是一项2 × 2析因、反应适应性、随机对照的仰卧/俯卧位临床试验。 在45个儿科重症监护室（PICU; 30个美国，（15）至少 5年的干预经验。最多1000例重度PARDS患者将随机分配至 四组之一（仰卧/CMV;俯卧/CMV;仰卧/HFOV;俯卧/HFOV），按年龄组（<1; 1-7; 8- 10）分层 17岁）和直接/间接肺损伤。在400例患者提供以下信息后，将开始缓解适应性随机化 主要结局（无呼吸机天数）的完整数据。在预先计划时显示劣效性的任何组 将取消随机化更新分析，以增加剩余组的分配。前景 当任何一组在回答研究时表现出优越性或无效时， 问题将按照主要分析的意向治疗和收到的符合方案数据进行分析。 前景数据协调中心（DCC）将与临床协调中心合作， 通过实现这些特定目标（SA），启动、执行和完成拟议试验： SA 1：为美国和国际提供最先进的数据管理和数据监控流程 前景入组、出院后随访和最终数据存档。 SA 2：监测研究入组和进展、研究中心性能、方案依从性和患者安全性， 支持研究协调以及数据和安全性监查委员会（DSMB）的需求。 SA 3：进行随机化更新分析，以帮助做出关于反应自适应的决策 随机化以及中期分析，用于审查DSMB报告的结局和安全性数据。 SA 4：使用现代统计学方法为初级和次级研究论文提供高质量的统计分析 统计方法和图表程序，并协助迅速传播调查结果。 这项临床试验将为该领域考虑重大变革提供必要的明确证据 在临床实践中护理重症PARDS患儿。