Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

• 批准号: 10248817
• 负责人: Athena F. Zuppa
• 金额: $ 9.28万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10248817
• 关键词: Address; Anti-Inflammatory Agents; Award; Beds; Blocking Antibodies; Budgets; Caring; Child; Childhood; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical and Translational Science Awards; Collaborations; Collection; Companions; Complement; Contracts; Country; Critical Care; Critical Illness; Critically ill children; Data; Data Collection; Data Coordinating Center; Development; Discipline of Nursing; Disease; Dose; Faculty; Family; Feedback; Functional disorder; Funding; Good Clinical Practice; Granulocyte-Macrophage Colony-Stimulating Factor; Home; Human; Immune; Immune Targeting; Immunophenotyping; Immunosuppression; Individual; Infant; Institutes; Institution; Institutional Review Boards; Interleukin 6 Receptor; Interleukin-1 Receptors; International; Intervention; Journals; Leadership; Medical; Medicine; Mentors; Mentorship; Methods; Mission; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multiple Organ Failure; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Network Infrastructure; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patients; Pediatric Hospitals; Pediatric Research; Performance; Persons; Phenotype; Philadelphia; Physician Executives; Population; Population Heterogeneity; Procedures; Protocols documentation; Public Health; Publications; Recombinants; Reporting; Research; Research Personnel; Research Training; Risk Factors; Role; Sampling; Science; Scientist; Sepsis; Site; Syndrome; System; Talents; Time; Training; Translational Research; United States National Institutes of Health; anakinra; base; career development; clinical center; clinical research site; disability; electronic data; expectation; experience; health related quality of life; immune function; immunoregulation; immunosuppressed; innovation; meetings; mortality; news; next generation; participant enrollment; patient population; pediatric department; personalized medicine; phenomics; professor; programs; racial and ethnic; racial diversity; sample collection; septic; socioeconomics; square foot; success; tertiary care; tocilizumab

PROJECT SUMMARY/ABSTRACT – Children’s Hospital of Philadelphia The Collaborative Pediatric Critical Care Research Network (CPCCRN) is essential to advancing the science and practice of pediatric critical care medicine. The overall aim of this site proposal is for Children’s Hospital of Philadelphia (CHOP), under the continued leadership of Athena Zuppa and Robert Berg, to continue as a clinical site in the new and expanded CPCCRN. Drs. Zuppa and Berg, site-PIs for the past 11 years, are pediatric intensivists with a wealth of clinical and translational research experience, who have successfully mentored many junior investigators and produced numerous scientific publications for the CPCCRN. CHOP is a free-standing, tertiary care, academic children’s hospital located in Philadelphia that serves children and families with diverse racial, ethnic, and socioeconomic backgrounds. CHOP, one of the largest children’s hospitals in the country, is a 559-bed children’s hospital with 49 pediatric medical and surgical subspecialties, a staff of over 14,585, a faculty of 860, and an annual operating budget of $3.2 billion. CHOP is home to one of the largest pediatric research programs in the country with more than $147 million in total federal awards and an annual budget of more than $404 million (FY19). The “Personalized Immunomodulation in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)” trial proposed in this application is a large RCT of personalized, targeted management of immune function in children with sepsis-induced MODS. The trial addresses the hypothesis that immunosuppressed children will benefit from granulocyte macrophage-colony stimulating factor (GM-CSF), and children with hyperinflammation will benefit from targeted anti-inflammatory therapy with anakinra (recombinant IL-1 receptor antagonist) or tocilizumab (IL-6 receptor blocking antibody). Benefit will be evaluated in terms of short- and long-term health-related quality of life. This study builds on CPCCRN studies that have demonstrated the existence of specific immune phenotypes among children with sepsis-induced MODS, and successful reversal of immune suppression by administration of the GM-CSF. It also complements the ongoing NICHD R01-funded study investigating the risk factors for immunoparalysis in pediatric MODS, of which Dr. Zuppa is a co-PI. This study proposes a transformative approach to personalized immune-targeted care of the septic child. Drs. Zuppa and Berg and their research team are thoroughly familiar with the CPCCRN studies on which this trial is based including methods of sample collection and processing for immunophenotyping, dosing and administration of GM-CSF, and collection of short- and long-term sepsis- related outcomes. Drs. Zuppa and Berg, and the ancillary site PI Dr. Neal Thomas have the full support of their respective institutions to participate in the CPCCRN, and are strongly committed to collaboration with other CPCCRN sites and the Data Coordinating Center, as well as the inclusion and mentoring of junior investigators in CPCCRN activities.

项目摘要/摘要 - 费城儿童医院 协作小儿重症监护研究网络（CPCCRN）对于推进科学至关重要 和小儿重症监护医学的实践。该站点建议的总体目的是针对儿童医院 在雅典娜·祖帕（Athena Zuppa）和罗伯特·伯格（Robert Berg）的持续领导下，费城（CHOP）继续担任 新的和扩展的CPCCRN中的临床部位。博士。 Zuppa和Berg，过去11年的现场PI是 有大量临床和翻译的研究经验的小儿浓缩主义者成功 指导了许多初级研究人员，并为CPCCRN制作了许多科学出版物。切碎 位于费城的一家独立的三级护理，学术儿童医院，为儿童提供服务 具有潜水员种族，种族和社会经济背景的家庭。 Chop，最大的儿童之一 该国的医院是一家559张病床的儿童医院 超过14,585人，860名教职员工，年度运营预算为32亿美元。 Chop是其中之一的家 该国最大的儿科研究计划，联邦总奖项超过1.47亿美元， 年度预算超过4.04亿美元（FY19）。败血症引起的个性化免疫调节 多器官功能障碍综合征（MOD）”在此应用中提出的试验是很大的RCT 具有败血症诱导的MOD的儿童免疫功能的个性化，针对性的管理。试验 解决以下假设，即免疫抑制儿童将受益于粒细胞巨噬细胞殖民地 刺激因子（GM-CSF）和过度炎症的儿童将受益于靶向抗炎 用anakinra（重组IL-1受体拮抗剂）或tocilizumab（IL-6受体阻断抗体）治疗。 将根据短期和长期与健康相关的生活质量评估福利。这项研究基于 CPCCRN研究表明患有儿童的特定免疫型 败血症引起的mod，并通过给药GM-CSF成功地逆转免疫抑制。它 还了解正在进行的NICHD R01资助的研究，研究了免疫分析的危险因素 儿科mods，其中Zuppa博士是Co-Pi。这项研究提出了一种变革性的个性化方法 化粪池儿童的免疫靶向护理。博士。 Zuppa和Berg及其研究团队非常熟悉 通过CPCCRN研究，该试验基于样本收集和处理方法 用于免疫表型，剂量和给药GM-CSF，并收集短期和长期败血症 相关结果。博士。 Zuppa和Berg，以及辅助网站Pi Neal Thomas博士得到了他们的全部支持 各自参加CPCCRN的机构，并强烈致力于与其他机构合作 CPCCRN站点和数据协调中心，以及初级研究人员的纳入和心理 在CPCCRN活动中。