Randomized Trial Comparing Two Treatment Protocols for Severe Traumatic Brain Injury in Children Aged 1 to 12 in Latin America

What this Trial Is About

Researchers are evaluating two different management protocols for children aged 1 to 12 years with severe traumatic brain injury sTBI in Latin America. The study aims to determine if using a treatment approach guided by invasive intracranial pressure ICP monitoring leads to better outcomes compared to a protocol based solely on imaging and clinical exams. This trial builds on previous adult studies and addresses the unique needs of pediatric patients to improve care and guide global clinical practice. The study randomly assigns children to one of two treatment groups. One group receives care following a protocol that uses invasive ICP monitoring to guide management decisions, based on recommendations from the Brain Trauma Foundation Guidelines. The other group follows the CREVICE protocol, which manages sTBI using imaging and clinical examination without ICP monitoring. Both protocols focus on aggressive management of sTBI. The trial is conducted in eight pediatric intensive care units in Latin America, aiming to strengthen research skills among local pediatric intensivists. Participants will be closely monitored during their hospital stay, with the study measuring outcomes such as quality of life using the Pediatric Quality of Life Inventory PedsQL at three and six months, functional recovery with the Glasgow Outcome Scale - Extended Pediatric GOS-E Peds, mortality rates, brain-specific treatments, and length of stay in intensive care. Data will be collected for up to six months after injury to assess the effects of the two management strategies on recovery and complications.

Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics