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

• 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
• 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

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 在严重的脑损伤（STBI）中幸存下 发展和未来的可能性。全球，TBI是儿童死亡和残疾的主要原因 和青少年。在美国，小儿TBI的年发病率大于MS，HIV/AIDS，脊髓 损伤和乳腺癌合并1。尽管不是严格的小儿疾病，但这种比较说明了 我们正在解决的小儿全球健康流行病的大小和重要性。 我们进行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：是否使用协议与颅内压的信息 （ICP）监测直接对患有STBI的儿童改善结果的治疗与积极的管理 仅基于成像和临床检查的协议？这是我们成人ICP研究2，发现没有 结果差异，并引起了对STBI患者的治疗指南的重新思考> 13。一个单独的 研究是必不可少的，因为儿童不仅是小成年人，而且某些治疗方法带有与年龄有关 额外的风险。因此，研究结果将为我们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，基础设施和实践模式是 最佳的内部有效性和资源代表发展中国家的创伤护理。成功 青少年/成人最佳旅行试验，在类似环境中收集了高质量的数据（引用> 900次） 强调了这种方法的可行性。 具体目的：在428名来自7个拉丁美洲儿科的Stbi儿童的III期随机优势试验中 创伤中心，测试使用协议指导的STBI管理结果的影响 ICP使用成像和临床检查指导治疗的方案来监视与管理。 假设1：患有严重TBI的儿童，其急性护理治疗是根据数据进行的 从ICP监测中将显着降低死亡率，更高的生活质量和6个月的全球结果 与基于成像和临床检查方案进行治疗的治疗的人相比。这 功能恢复的主要度量是6个月时的PEDSQL。次要措施是Gose-Peds。 假设2：将ICP监测纳入STBI患者护理将最大程度地减少次要并发症， 减少ICU的住院时间并减少大脑特异性治疗。 具体目的：我们将培训新的研究人员，以研究如何进行高质量的科学研究， 并将扩大我们与我们一起工作的人员的培训，以巩固以前的能力 - 建立努力，并发起新的努力。