Pediatric Severe Traumatic Brain Injury in Latin America – A Randomized Trial Comparing Two Management Protocols

拉丁美洲儿童严重创伤性脑损伤 — 比较两种治疗方案的随机试验

基本信息

批准号：
10297872
负责人：
RANDALL M CHESNUT
金额：
$ 65.15万
依托单位：
UNIVERSITY OF WASHINGTON
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：
2021-08-01 至 2026-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10297872
关键词：
13 year old AIDS/HIV problem Address Adolescent Adult Algorithms Argentine Attention Brain Brain Injuries Caring Cause of Death Child Childhood Collaborations Consensus Data Databases Developing Countries Development Disease Environment Epidemic Equipment and supply inventories Future Goals Guatemala Guidelines Human Resources Image Impairment Incidence Infrastructure Injury Intensive Care Intracranial Pressure Investigation Journals Latin America Latin American Learning Length of Stay Literature Measures Monitor Neurological outcome New England Observational Study Outcome Outcome Measure Patient Care Patient-Focused Outcomes Patients Pattern Phase Policies Population Prevention Measures Protocols documentation Publishing Quality of life Randomized Randomized Controlled Trials Recommendation Recovery Recovery of Function Research Research Ethics Research Personnel Resources Risk Site Societies Spinal cord injury Subgroup TBI treatment Testing Thinking Time Training Traumatic Brain Injury Treatment Protocols Ventricular Violence Work acute care age related base biomedical referral center care outcomes clinical examination clinical practice cost disability efficacy testing experience global health improved improved outcome injury burden low and middle-income countries malignant breast neoplasm mortality non-invasive imaging pediatric trauma pediatric traumatic brain injury post-trauma programs randomized trial targeted treatment trauma care trauma centers treatment guidelines trend trial comparing

项目摘要

Abstract Children who survive severe traumatic brain injury (sTBI) live with profound impairments that alter their development and future possibilities. Worldwide, TBI is the leading cause of death and disability among children and adolescents. In the US, the annual incidence of pediatric TBI is greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined1. Although not strictly pediatric diseases, this comparison illustrates the magnitude and importance of the pediatric global health epidemic we are addressing. Our primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a critical TBI management question: Does using a protocol with information from intracranial pressure (ICP) monitoring to direct treatment of children with sTBI improve outcomes vs an aggressive management protocol based on imaging and clinical examination alone? This follows on our adult ICP study2 which found no outcome differences and has occasioned re-thinking of treatment guidelines for sTBI patients >13. A separate study is essential because children are not simply small adults and some treatment approaches carry age-related additional risks. Thus, study findings will inform US and global clinical practice. This trial will be conducted in 7 Latin American pediatric ICUs where infrastructures and practice patterns are optimal for strong internal validity and resources represent trauma care in the developing world. The successful adolescent/adult BEST TRIP trial, which collected high-quality data in similar environments (cited > 900 times) underscores the feasibility of this approach. Specific Aim: In a Phase III randomized superiority trial in 428 children with sTBI from 7 Latin American pediatric trauma centers, test the effect on outcomes of management of sTBI guided by a protocol using information from ICP monitors vs. management using a protocol that uses imaging and clinical exams to guide treatment. Hypothesis #1: Children with severe TBI whose acute care treatment is managed using a protocol based on data from ICP monitoring will have significantly lower mortality and better quality of life and global outcome at 6 months post-trauma than those whose treatment is managed with a protocol based on imaging and clinical exam. The primary measure of functional recovery is the PedsQL at 6 months. A secondary measure is GOSE-Peds. Hypothesis #2: Incorporating ICP monitoring into sTBI patient care of will minimize secondary complications, decrease length of stay in ICU and decrease brain-specific treatments. Specific Aim: We will train personnel in centers new to research in how to conduct high-quality scientific studies, and will extend the training for the personnel with whom we have been working, solidifying previous capacity- building efforts, and initiating new efforts.

抽象的严重创伤性脑损伤 (sTBI) 中幸存下来的儿童会遭受严重的损伤，从而改变他们的生活发展和未来的可能性。在世界范围内，TBI 是儿童死亡和残疾的主要原因和青少年。在美国，儿童 TBI 的年发病率高于 MS、HIV/AIDS、脊髓损伤和乳腺癌合并1。虽然不是严格意义上的儿科疾病，但这一比较说明了我们正在应对的儿科全球卫生流行病的严重程度和重要性。我们科学研究的主要重点是进行高质量的随机对照试验解决关键的 TBI 管理问题：是否使用包含颅内压信息的协议 (ICP) 监测直接治疗 sTBI 儿童可改善预后，而不是积极的治疗仅基于影像学和临床检查的方案？这是我们的成人 ICP 研究2 的结果，该研究没有发现结果差异，并引发了对 sTBI 患者 >13 的治疗指南的重新思考。一个单独的研究至关重要，因为儿童不仅仅是小成年人，而且一些治疗方法与年龄有关额外的风险。因此，研究结果将为美国和全球临床实践提供信息。该试验将在 7 个拉丁美洲儿科 ICU 中进行，这些重症监护室的基础设施和实践模式均处于领先水平。最佳的强大的内部有效性和资源代表了发展中国家的创伤护理。成功者青少年/成人 BEST TRIP 试验，在类似环境中收集高质量数据（被引用 > 900 次）强调了这种方法的可行性。具体目标：在一项针对来自 7 个拉丁美洲儿科的 428 名 sTBI 儿童进行的 III 期随机优势试验中创伤中心，使用来自以下信息的协议测试对 STBI 管理结果的影响： ICP 监测与使用使用影像和临床检查来指导治疗的方案进行管理。假设#1：患有严重 TBI 的儿童，其急性护理治疗是使用基于数据的方案进行管理的 ICP 监测将显着降低死亡率并提高 6 个月后的生活质量和总体结果创伤后的患者比那些通过基于影像和临床检查的方案进行治疗的患者。这功能恢复的主要衡量标准是 6 个月时的 PedSQL。次要措施是 GOSE-Peds。假设#2：将 ICP 监测纳入 sTBI 患者护理将最大限度地减少继发并发症，减少 ICU 住院时间并减少针对大脑的治疗。具体目标：我们将培训新研究中心的人员如何进行高质量的科学研究，并将扩大对与我们一起工作的人员的培训，巩固以前的能力- 扎实工作，开创新工作新局面。