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: 10670240
• 负责人: Athena F. Zuppa
• 金额: $ 8.98万
• 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/10670240
• 关键词: Address; Agreement; 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; Dedications; Development; Discipline of Nursing; Disease; Dose; Eligibility Determination; Ethnic Origin; Faculty; Family; Feedback; Functional disorder; Funding; Good Clinical Practice; Granulocyte-Macrophage Colony-Stimulating Factor; Home; Human; Immune; Immune Targeting; Immunophenotyping; Immunosuppression; Individual; Infant; 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; Organ; Outcome; Participant; Patients; Pediatric Hospitals; Pediatric Research; Performance; Persons; Phenotype; Philadelphia; Physician Executives; Population; Population Heterogeneity; Procedures; Productivity; Protocols documentation; Public Health; Publications; Race; 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; antagonist; 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 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 小儿重症监护医学的实践。 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CPCCRN中的临床部位。 具有丰富的临床和转化研究经验的儿科强化学家 指导了许多初级研究人员，并为CPCCRN制作了许多科学出版物。 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 有种族，种族和社会经济背景的家庭。 该国的Hosspitals是一家559张床的儿童医院 超过14,585的工作人员，860名教职员工，年度运营预算为32亿美元。 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）。 多器官功能障碍综合征（MODS）“此应用中的试验是很大的RCT 败血症诱导的MOD的个性化，针对性的管理。 解决以下假设：不受欢迎的孩子将受益于粒细胞巨噬细胞殖民地 刺激因子（GM-CSF）和高炎症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。 福利将以短期和长期与健康相关的生活质量进行评估。 CPCCRN研究脑中的患者中存在特定的免疫表型。 败血症诱导的mod和通过GM -CSF的给药成功地逆转了免疫增长 还补充了正在进行的NICHD R01资助的研究，研究了免疫分析的危险因素 小儿mods，其中Zuppa博士是该研究。 Zuppa和他们的研究教学教学教学师的免疫性护理 通过对Whis试验的CPCCRN研究，基于样本收集和加工的方法 用于免疫表型，剂量和给药GM-CSF，并收集短期和长期败血症 相关的结果。 尊敬的研究所机构参与CPCCRN，并强烈努力与其他合作合作 CPCCRN站点和数据协调中心，以及初级研究人员的包含和指导 在CPCCRN活动中。