Collaborative Pediatric Critical Care Research Network - Clinical Site

儿科重症监护协作研究网络 - 临床网站

基本信息

批准号：
10248820
负责人：
Patrick Sean McQuillen
金额：
$ 8.18万
依托单位：
UNIVERSITY OF UTAH
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：
2021-08-13 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10248820
关键词：
Address Admission activity Ancillary Study Award Beds Biological Markers Brain Injuries California Child Child Development Child Health Childhood Clinical Clinical Research Clinical Trials Coagulation Process Contracts Critical Care Critical Illness Data Data Coordinating Center Databases Faculty Family Funding Gene Expression Geography Goals Good Clinical Practice Health Hypoxemia Immune response Immunocompromised Host Individual Infant Inflammation Institutes Lead Los Angeles Lung Machine Learning Manuscripts Mentors Morbidity - disease rate Multi-Institutional Clinical Trial National Heart, Lung, and Blood Institute Natural Language Processing Network Infrastructure Nurses Obesity Outcome Pediatric Acute Lung Injury Pediatric Hospitals Performance Physiology Population Procedures Protocols documentation Publishing Recording of previous events Research Research Personnel Research Training Respiratory Failure Risk San Francisco Scientist Sepsis Site Talents United States National Institutes of Health Universities Work base clinical research site design early-career faculty expectation experience immunoregulation innovation lung microbiome meetings metabolomics metatranscriptomics mortality outcome prediction participant enrollment programs prospective racial and ethnic racial diversity success ward

项目摘要

PROJECT ABSTRACT - University of California Consortium The University of California, San Francisco (UCSF) Benioff Children's Hospital has been a Clinical Site in the Eunice Kennedy Shriver National Institutes of Child Health and Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN) since 2014 (3rd cycle) and is enthusiastic about participating as a Clinical Hub in the newly organized and expanded network. During the 3rd cycle, Dr Anil Sapru (original PI) relocated to University of California, Los Angeles (UCLA) and UCLA joined UCSF as a consortium site. More recently UCSF has affiliated with the former Children's Hospital Oakland resulting in the new Benioff Children's Hospitals at San Francisco (BCHSF) and Oakland (BCHO). Thus, BCHSF and BCHO, along with UCLA, will comprise a clinical consortium or hub site in the present site application. We will work closely with our ancillary site, University of California, Davis Children's Hospital. In combination with this partner, our site will provide access to 104 PICU beds with approximately 4500 annual admissions, enabling us to participate fully in the “Personalized Immunomodulation in Sepsis-induced MODS” trial described in the Overall Component of this application. Our site proposal has three specific aims: Specific Aim 1. Actively collaborate in implementation of CPCCRN, including participation on the Steering Committee and other committees, attendance at meetings, facilitating contracting with the Data Coordinating Center, and complying with the standard operating procedures and performance expectations of the network. Specific Aim 2. Provide opportunities for young investigators to participate in CPCCRN meetings, committees, or trial implementation, with the goal of developing these talented individuals into fundable clinician scientists. Specific Aim 3. Implement the Personalized Immunomodulation in Sepsis-induced MODS trial, including enrollment of patients by trained research staff, adhering to the study protocol, prompt data entry, and full compliance with Good Clinical Practice (GCP) and other regulatory requirements.

项目摘要 - 加州大学联盟加州大学旧金山分校 (UCSF) 贝尼奥夫儿童医院已成为该地区的临床中心尤尼斯·肯尼迪·施赖弗国家儿童健康与发展研究所 (NICHD) 儿科协作中心自 2014 年（第三周期）起加入重症监护研究网络 (CPCCRN)，并热衷于作为新组织和扩展网络中的临床中心在第三个周期中，Anil Sapru 博士（原 PI）。迁至加州大学洛杉矶分校 (UCLA)，并且 UCLA 作为联盟站点加入了 UCSF。最近，加州大学旧金山分校 (UCSF) 与前奥克兰儿童医院建立了新的贝尼奥夫儿童医院 (Benioff Children's Hospital) 旧金山 (BCHSF) 和奥克兰 (BCHO) 的医院因此，BCHSF 和 BCHO 以及加州大学洛杉矶分校 (UCLA) 将共同开展这项工作。在当前站点应用程序中包含临床联盟或中心站点，我们将与我们的辅助人员密切合作。网站，加州大学戴维斯分校儿童医院与该合作伙伴合作，我们的网站将提供。拥有 104 张 PICU 床位，每年入院人数约为 4500 人，使我们能够充分参与本试验总体部分中描述的“脓毒症诱导的 MODS 中的个性化免疫调节”试验我们的站点提案有三个具体目标：具体目标 1. 积极配合实施。 CPCCRN 的参与，包括参与指导委员会和其他委员会、出席会议、促进与数据协调中心签订合同，并遵守标准操作网络的程序和绩效期望具体目标 2. 为年轻人提供机会。研究人员参加 CPCCRN 会议、委员会或试验实施，目的是将这些有才华的人培养成可资助的临床科学家。具体目标 3. 实施脓毒症诱发的 MODS 试验中的个性化免疫调节，包括由经过培训的患者入组研究人员遵守研究方案、及时输入数据并完全遵守 Good Clinical 实践 (GCP) 和其他监管要求。