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临床试验/NCT02731781
NCT02731781Unknown不适用

Trauma Infant Neurological Score (TINS) as a Prognostic Factor and Guideline for CT Scan in Infants 24 Months Old or Less

Laniado Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Neurological outcome at Discharge or within 1 month

研究概览

简要总结

Traumatic brain injury (TBI) is the major cause of disability and death among the younger population. In the Pediatric population Head trauma may be responsible for primary and secondary brain damage. Primary brain injury results from a direct mechanical damage at the time of injury, whereas secondary injury is caused by further cellular damage that develops hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in the abcence of neurological deficit or early deterioration. On the other hand, symptoms such as vomiting and restlessness may be present even in the case of minor head injury, and unnesessary scaning (CT) may be performed in many centers just because clinical judgment is problematic in this particular age. Some intracranial injuries may be imminent, such as evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for emergency evaluation of head injured patients. In children, several scores were introduced, including the Children's Coma Score (CCS), however they have been found problematic to use in the very young population, since accurate evaluation of communication in CCS is hard, and there is insufficient relevant parameters uncorporated into the score that may have significant importance in this particular age group. In TINS (Trauma Infant Neurological Score) we characterized the clinical parameters and the mechanism of trauma in a simplified method. As previously published, this score has been used by us and by other groups, in retrospective studies. Still, in the lack of prospective studies using TINS, there are no optimal guidelines to perform computed tomography (CT) in this unique population, and TINS has not prospectively been challenged as a predictor tool for outcome. In this prospective study we will approach these issues.

详细描述

Methods:

200 infants (<2 years old) will be enrolled into the study. Clinical data will be gathered from the emergency room file, and in case of admission from the discharge letter and the clinical file. Based on the current protocols of treatment and diagnosis of children with head injury, CT will be performed according to the current axisting protocols. No intervention, imaging, or treatment will be administered different from the current protocol used in the hospital, according to the existing guidelines. Both TINS and Children's Glasgow Coma Scale (CCS) score was applied, based on the clinical data obtained from the files. If imaging is peformed data will be recoreded. As all children with head trauma are invited routinely to follow-up clinic within the 1st year after injury, this data will be recoreded as well.

As there is no violation of current treatment protocols, or any additional exams or interventions due to the study - and since the data is obtained from the files, informed concent will not be necessary.

The data will be coded by the treating doctors into a database that will be coded in a manner that identification of the child is not possible by the statisticians or by people who are not involved in treatment and follw up.

The database used will be a "filemaker pro" data base, with concequent numbering of the infant enrolled.

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
24 Hours 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age from birth till 24 months
  • After Head Trauma (any type or severity)
  • Arrival to Emergency room

排除标准

  • 未提供

结局指标

主要结局

Neurological outcome at Discharge or within 1 month

时间窗: up to 1 month

clinical follow up and examination at discharge and clinics within 1 month after trauma

次要结局

  • Neurological outcome at 1 year after head injury in the Infant(up to 1 year after trauma)

研究者

发起方
Laniado Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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