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临床试验/NCT04157634
NCT04157634Unknown不适用

Prediction of Neurological Outcome of Children After a Moderate or Severe Traumatic Brain Injury, Based on an Integrated Predictive Model (Serum Biomarkers, Heart Rate Variability, Computerized Classifier Output)

St. Justine's Hospital0 个研究点目标入组 70 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
主要终点
Association with poor neurological outcome

研究概览

简要总结

This study aims to develop a integrated predictive model based on serum biomarkers, HRV, and an innovative computerized classifier output, to predict the patient long term neurological outcome after a moderate or severe TBI in children.

详细描述

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in children. Most children with moderate and severe TBI have long term sequelae including neurological deficit, cognitive impairment and behavioural disorders. In the acute care setting, neither clinicians nor researchers are able to adequately predict the long term outcome of children with TBI, consequently limiting their ability to tailor medical care, rehabilitation and support services. Improving our understanding of a TBI patient's exact cerebral status and prognosis is a critical step toward optimized and personalized patient management. In this research study, an innovative and integrated model will be developed to improve the prognostication in the early phase of a TBI. This model will combine key clinical variables commonly collected in the acute care setting and combine these with cutting-edge empirical measures: 1) biomarkers; 2) a new physiological monitoring based on heart-rate variability (HRV) to assess the integrity of the autonomic system; and 3) a computerized classification tool developed using the concept of artificial intelligence to continuously categorize the patient's cerebral status.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children 1) <18 years; 2) admitted to the Paediatric Intensive Care Unit at the Centre Hospitalier Universitaire Ste-Justine; 3) moderate (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8), assessed after initial resuscitation; 4) admitted to the Paediatric Intensive Care Unit less than 24 hours after the initial TBI and 5) written parental consent. Patients with either inflicted or accidental TBI will be included as they characterize different but important population, our model should be valuable for both.

排除标准

  • Children 1) suspected of being brain death at the time of Paediatric Intensive Care Unit entry (GCS 3 and loss of all brain stem reflexes); 2) with a pacemaker (HRV monitoring unreliable); and/or 3) patients or parents who do not speak or read English or French.

结局指标

主要结局

Association with poor neurological outcome

时间窗: We will assess neurocognitive function of patients at 6 ±2 months following the discharge from the Pediatric Intensive Care Unit

A poor neurological outcome will be defined as on death or neurocognitive dysfunction in survivors

次要结局

  • Adverse events(In the 72 hours following TBI)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurence Ducharme-Crevier

Paediatric Intensivist

St. Justine's Hospital

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