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临床试验/NCT03050970
NCT03050970已完成不适用

Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 8,802 人开始时间: 2017年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,802
试验地点
1
主要终点
Presence of a clinically-important traumatic brain injuries (ciTBI)

研究概览

简要总结

The purpose of this study is to validate a clinical decision rule for the management of minor head trauma in infants aged less than two years, constructed with the intention of minimizing the rate of computed tomography scans ordering.

详细描述

Apparently minor head trauma (MHT), defined by a Glasgow coma scale score (GCS) of 14-15, is the most frequently assessed group among the population of children attending Emergency Department (ED) for head trauma. Less than 1% of children with MHT have a clinically important traumatic brain injury (ciTBI) that is requiring immediate and specific care, especially neurosurgery. Those ciTBI should be identified rapidly. Assessment of children < 2 years is particularly difficult. This may promote excessive computed tomography (CT) scans ordering in this age group, while the youngest are the most sensitive to the risk of secondary malignity induced by ionizing radiation from CT scan. In USA, 31% of children < 2 years with MHT undergo CT scan. Data for CT scan use in France are unavailable and subjected to practice variations. The predictive values of TBI clinical variables such as vomiting, immediate loss of consciousness, impact seizure, severe injury mechanism, scalp hematoma or skull fracture, are controversial. A short clinical observation of children with such signs or post-traumatic symptoms before making the decision regarding CT scan ordering seems to be beneficial, allowing selective CT scan use for children whose symptoms fail to resolve. To improve patient care, clinical decision rules attempting to risk-stratify the need for a scan have emerged in the literature.

Age-based PECARN rule derived and validated in the larger cohort of 10 718 children < 2 years is the reference in the management of minor head trauma. The PECARN rule identifies ciTBIs with an optimal sensitivity but with a high rate of normal scans or identifying a non-significant lesion (expected CT scans rate: 23%; ciTBI: 0,85%). This North American rule is recommended by the Emergency Medicine French Society for the management of minor head injury. This study aims to evaluate the performance of the PELICAN rule, a decision rule for the management of apparently minor head trauma in children < 2 years that proposes targeted indications for CT scan use and defines precise indications for clinical observation. The PELICAN rule was built after a literature review of the predictive values of TBI clinical variables with the intention of minimizing the CT scans rate without missing any ciTBI.

The primary objective is to assess the performance of the PELICAN clinical prediction rule for identifying clinical-important traumatic brain injuries after apparently minor head trauma (GCS 14-15) in infants less than 2 years. The performance of the PECARN TBI prediction rule when applied to a large national French population will also be assisted and compared to that of PELICAN rule in terms of security, efficacy and expected impact on CT ordering.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged less than 2 years presenting to pediatric emergencies for evaluation within 24 hours of an apparently minor blunt head trauma, defined by a pediatric Glasgow coma scale score of 14 or 15 at initial clinical assessment
  • Non opposition from parents to their child inclusion and collect of these data
  • Child with social insurance

排除标准

  • Trivial head injury
  • Neurosurgical history
  • Pre-existing neurological disorder
  • Bleeding disorder
  • Suspected child abuse
  • Open fracture
  • Penetrating skull injury
  • Polytrauma and substantial non cranial serious injury
  • Isolated facial trauma
  • Imaging performed before ED visit
  • Prior inclusion of the child in the study

结局指标

主要结局

Presence of a clinically-important traumatic brain injuries (ciTBI)

时间窗: 7 days after head trauma

Clinically-important traumatic brain injury defined by: death, intubation \> 24h, neurosurgical intervention and/or admission \> 2 nights for head injury with traumatic brain injury on CT scan

次要结局

  • Rate of CT scans that would be recommended by the PELICAN rule applied in the study population(24 hours following the initial evaluation)
  • Rate of Admission for short ED clinical observation expected by the application of PELICAN rule(24 hours after head trauma)
  • Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group(Initial emergency clinical evaluation)
  • Rate of CT scan use in practice(7 days after head trauma)
  • Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule(7 days after head trauma)
  • Number of patients with TBI on CT undergoing neurosurgery(7 days after head trauma)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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