METHODS: We will conduct a European, prospective, multicentre study, the BRAINI-2 paediatric study, in 20 centres in France, Spain and Switzerland with an inclusion period of 30 months for a total of 2880 children and adolescents included. To assess the performance of GFAP and UCH-L1 used separately and in combination to predict ICLs on CT scans (primary objective), 630 children less than 18 years of age with mild TBI, defined by a Glasgow Coma Scale score of 13-15 and with a CT scan will be recruited. To evaluate the potential of GFAP and UCH-L1 in predicting the prognosis after TBI (secondary objective), a further 1720 children with mild TBI but no CT scan as well as 130 children with moderate or severe TBI will be recruited. Finally, to establish age-specific reference values for GFAP and UCH-L1 (secondary objective), we will include 400 children and adolescents with no history of TBI.
BACKGROUND: This study has received ethics approval in all participating countries. Results from our study will be disseminated in international peer-reviewed journals. All procedures were developed in order to assure data protection and confidentiality.
BACKGROUND: NCT05413499.
方法:我们将进行欧洲,prospective,多中心研究,BRAINI-2儿科研究,在法国的20个中心,西班牙和瑞士的纳入期为30个月,共纳入2880名儿童和青少年。为了评估GFAP和UCH-L1在CT扫描(主要目标)中单独和组合使用以预测ICL的性能,630名18岁以下儿童患有轻度TBI,由13-15的格拉斯哥昏迷量表定义,并进行CT扫描。评价GFAP和UCH-L1对TBI后预后的预测价值(次要目标)。另外,我们将招募1720名轻度TBI但未进行CT扫描的儿童以及130名中度或重度TBI儿童.最后,为GFAP和UCH-L1(次要目标)建立特定年龄的参考值,我们将包括400名没有TBI病史的儿童和青少年。
背景:该研究已在所有参与国家/地区获得伦理学的批准。我们的研究结果将在国际同行评审期刊上传播。所有程序都是为了确保数据保护和机密性而制定的。
背景:NCT05413499。