Pediatric Traumatic Brain Injury in Latin America

描述（由申请人提供）：拉丁美洲的创伤性脑损伤（TBI）发生率是国际平均水平的三倍。在世界范围内，脑外伤是儿童和青少年死亡和残疾的主要原因。非神经性、继发性并发症如败血症和肺炎的死亡率和发病率很高。创伤性脑损伤的出院后康复很少甚至没有，对这些患者的随访护理也很少见。治疗方法因中心和地区而异。在资源允许的情况下，许多中心使用《婴幼儿、儿童和青少年创伤性脑损伤急性医疗管理指南》来指导他们的治疗决策。试点数据表明，这样做可能会改善结果。迫切需要对拉丁美洲的儿童脑外伤进行强有力的研究，以便进行诊断、治疗和预防。我们建议在拉丁美洲的儿科患者中进行一项TBI研究。它将在五个创伤中心进行；三个在阿根廷，一个在玻利维亚，一个在厄瓜多尔。这些中心代表了拉丁美洲治疗脑外伤可用资源的差异。我们的具体目标是：1；在一项随机对照试验中，测试家庭提供的家庭护理干预对中度至重度脑外伤患儿功能结局的影响。2. 在一项前瞻性观察性研究中，检验重症TBI患儿的医疗管理与预后之间的关系。3. 在一项前瞻性观察性研究中，测试资源可用性与中度至重度脑外伤患儿预后之间的关系。4. 建立拉丁美洲儿童脑外伤长期、前瞻性收集数据的登记册，可用于生成强有力的科学文献，从中可得出适用于资源贫乏环境的诊断、治疗、预后和预防指南。5. 在拉丁美洲脑损伤协会（LABIC）中建立可持续的能力，对患有神经创伤和其他重大脑部疾病的儿科人群进行持续的研究。我们估计的样本是720名急症护理患者；我们预计65%的患者将存活至出院，并将收集约420例患者的结果数据（占随访损失的10%）。我们假设随机接受家庭护理干预的患者比没有接受干预的患者有明显更好的功能状态。我们进一步假设，结果将与资源水平和医疗管理显著相关。

DESCRIPTION (provided by applicant): The incidence of traumatic brain injury (TBI) in Latin America is three times the international average. Worldwide, TBI is the leading cause of death and disability among children and adolescents. Mortality and morbidity due to non- neurological, secondary complications such as sepsis and pneumonia are high. There is little to no post-discharge rehabilitation for TBI, and follow-up care for these patients is rare. Treatment practices vary across centers and regions. Where resources allow, many centers use the Guidelines for the Acute Medical Management of TBI in Infants, Children, and Adolescents to guide their treatment decisions. Pilot data suggests that doing so may improve outcomes. There is an urgent need to conduct strong research about pediatric TBI in Latin America that can lead to diagnostics, treatment, and prevention. We propose to conduct a study of TBI in pediatric patients in Latin America. It will take place in five trauma centers; three in Argentina, one in Bolivia, and one in Ecuador. These centers represent the variation in resources available for treatment of TBI in Latin America. Our Specific Aims are: 1. In a randomized controlled trial, test the effect of a family-provided home care intervention on functional outcomes for pediatric patients who sustain moderate to severe TBI. 2. In a prospective, observational study, test the association between medical management and outcomes for pediatric patients with severe TBI. 3. In a prospective, observational study, test the association between resource availability and outcomes for pediatric patients with moderate to severe TBI. 4. Establish a registry of long-term, prospectively collected data about pediatric TBI in Latin America that can be used to generate strong scientific literature from which diagnostic, treatment, prognostic, and prevention guidelines - appropriate to resource-poor environments - can be derived. 5. Establish sustainable capacity in the Latin American Brain Injury Consortium (LABIC) to conduct ongoing research in pediatric populations with neurotrauma and other significant brain disorders. Our estimated sample is 720 acute care patients; we anticipate 65% will survive to discharge, and will collect outcomes data on approximately 420 patients (accounting for 10% loss to follow-up). We hypothesize that patients randomized to the home care intervention will have significantly better functional status than those who do not receive the intervention. We further hypothesize that outcome will be significantly associated with level of resources, and with medical management.