跳至主要内容
临床试验/CTRI/2025/03/083358
CTRI/2025/03/083358尚未招募不适用

Neuroprognostication in critically ill pediatric patients with moderate to severe traumatic brain injury: a prospective study

AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To evaluate the association of demographic variables, clinical variables, dependent variables and functional outcome

研究概览

简要总结

Traumatic brain injury (TBI) is the leading cause of death and disability in critically ill pediatric patients, affecting up to 500,000 children per year in the United States. It is estimated that as many as 62% of these patients with moderate to severe TBI experience disability. Although TBI associated death rates have decreased over last few decades, disabilities for children who survive TBI continue to have significant impact on the society.  Current treatment guidelines for pediatric patients with TBI are largely adopted from guidelines for adult patients  and to improve the neurological outcome for pediatric TBI, there is an unmet need to understand factors affecting outcome after pediatric TBI. Neurocritical care society have recently published the guidelines for neuroprognostication in critically ill adult patients with moderate to severe TBI. By Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, they conducted a systematic narrative review of the ten clinically relevant predictors and nine prediction models cited in the literature. In clinical variables, only the presence of bilateral pupillary nonreactivity on admission was deemed moderately reliable predictor for functional outcomes at 6 months or beyond. In terms of prediction models, the Corticosteroid Randomization After Significant Head Injury (CRASH)-basic, CRASH-CT (CRASH-basic extended by computed tomography features), International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT)-core, IMPACT-extended, and IMPACT-lab models were recommended as moderately reliable in predicting mortality at discharge and beyond and functional outcomes at 6 months and beyond. The advances in prognosticating outcome after the injury in critically ill pediatric patients with TBI have been limited despite of extensive research in randomized controlled trials. Neuroprognosticating predictors for pediatric patients with moderate to severe TBI are still lacking. Although several studies demonstrated that various demographic or clinical variables (age, sex, GCS, GCS P, lactate, PT, APTT, INR) as well as other parameters (diffuse axonal injury, inclusion of MRI) which can influence the outcome in pediatric TBI patients, these factors have not been rigorously evaluated in the development of prognostic indicators. Analysis of existing trauma databases in critically ill pediatric patients may elucidate factors associated with worse outcomes after TBI and, in turn, provide discussion regarding neuroprognostication and anticipated resources needed after injury.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • pediatric trauma patients with moderate to severe traumatic head injury between 0–18 years of either gender admitted in neuro intensive care unit.

排除标准

  • pediatric trauma patients with mild traumatic head injury between 0–18 years of either gender admitted in neuro intensive care unit.

结局指标

主要结局

To evaluate the association of demographic variables, clinical variables, dependent variables and functional outcome

时间窗: At 3 months

次要结局

未报告次要终点

研究者

发起方
AIIMS NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Indu kapoor

AIIMS NEW DELHI

研究点 (1)

Loading locations...

相似试验