Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 428
- 试验地点
- 14
- 主要终点
- Pediatric Quality of Life Inventory (PedsQL)
研究概览
简要总结
Narrative:
Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.
详细描述
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 for children/ adolescents with the US annual incidence 6 times greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined.
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 study 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 8 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 8 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will not go into the ICU when a study participant is being treated, unmasked study staff will not inform the outcome assessor which protocol was used for a participant. and outcome assessors will remind participant's parents to refrain for telling them which treatment protocol was used for the participant.
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form by the parent(s) or guardian(s)
- •Non-penetrating TBI
- •Admission to study hospital within 24 hours of injury
- •Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children < 2 years old and standard GCS for older children)
- •Age 1 through 12 years
- •Able to randomize:
- •Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR
- •Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)
排除标准
- •Motor GCS score of 6
- •GCS of 3 with bilaterally fixed and dilated pupils
- •Injury thought to be intentionally inflicted by a family member or caregiver.
结局指标
主要结局
Pediatric Quality of Life Inventory (PedsQL)
时间窗: 6 months after injury
PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0-100. Higher scores have better outcomes.
次要结局
- ICU length of stay(1 month average)
- Brain-specific interventions(1 month average)
- Glasgow Outcome Scale - Extended (GOS-E) Pediatric(3 and 6 months after injury)
- Mortality(3 and 6 months)
- Pediatric Quality of Life Inventory (PedsQL)(3 months after injury)
研究者
Randall M. Chesnut
Professor, School of Medicine
University of Washington