study assessing evaluation of the interest of serum s100b protein determination in the management of pediatric mild traumatic brain injury

Conditions: Craniocerebral Trauma; Pediatrics

Summary: mild traumatic brain injury (mtbi) is a very common reason for presentation to pediatric emergency departments. so as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (cct-scan) and/or short inpatient observation are prescribed. ultimately, the majority of these measures could be avoided and a large australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a cct-scan (3.24 for age 1-4 years). assay of a sensitive biomarker in blood, such as the s100b protein, has the potential to reduce the number of these unnecessary measures.

based on initial results from a previous prospective study, a multicenter interventional study will be necessary to validate the routine use of this biomarker .the ultimate goal is to include serum s100b assay in the current recommendations for m traumatic brain injury (mtbi) management based on the study of kupperman et al. (2009), as mtbi accounts for 5-8% of pediatric emergency admissions in france (60-100 per 100,000 children). the study of kuppermann et al. strongly dictated the recommendations for mtbi management by the french society of emergency medicine (sfmu) . then, from these 2 publications, the french society of pediatrics (sfp) redacted their recommendations after adjustment method recommendations for clinical practice, used by the french high authority of health (has) . the use of serum s100b assay as part of the management of pediatric mtbi should make it possible to reduce the number of additional examinations, in particular a 30% reduction in the number of cct-scans, with a resultant reduction in radiation exposure, known to be a risk factor for cancer. the study protocol corresponds to a diagnostic prospective, controlled, multicenter study using a randomized stepped wedge cluster design, in which pediatric patients (aged ≤ 16 years) presenting to the pediatric emergency room for mtbi with a gcs score of 15 will benefit from usual care ("conventional management" arm) in the control group, and from s100b management in the interventional group.

Eligibility criteria:
inclusion criteria: * age ≤ 16 years therapeutic management within 3 hours after tbi gcs score of 15 classically requiring hospitalization and/or cct-scan as per sfp recommendations (lorton et al., 2014). these criteria are: * for children aged under 2 years (cct-scan or hospitalization recommended according to physician's evaluation): * parietal or occipital scalp hematoma, * loss of consciousness for more than 5 seconds, * trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 0.9 meter), * abnormal behavior in the opinion of parents. * for children 2 years and older (cct-scan or hospitalization recommended according to physician's evaluation): * loss of consciousness at time of accident, * vomiting, * trauma due to serious accident (road accident with passenger ejected from vehicle or death of another person or rollover; pedestrian hit by a moving vehicle; cyclist not wearing a helmet; fall from a height greater than 1.5 meter), * severe headache. exclusion criteria: * patient already enrolled in another therapeutic trial with drug administration down syndrome melanoma refusal of child refusal of parents or legal guardian trauma more than 3 hours earlier gcs score of 13 or 14, or signs of skull fracture or lesions of the skull base (cct-scan recommended) children with tbi not requiring hospitalization and/or cct-scan as per sfp recommendations (lorton et al., 2014). this group is defined by the absence of the following criteria: * gcs score different from 15, * age \< 3 months, * seriousness of accident: * road accident with passenger ejected from vehicle or death of another person or rollover, * pedestrian hit by a moving vehicle, * cyclist not wearing a helmet. * fall: * of more than 0.9 m before age 2 years, * of more than 1.5 m after age 2 years. * loss of consciousness for 5 seconds or more, * inconsolable crying, * agitation, drowsiness, feeling "slowed down", obnubilation, * vomiting or headache, * facial or cranial hematoma, * otorrhea, rhinorrhea, * child under 2 years old, * loss of consciousness for less than 5 seconds, * unusual behaviour, * concern of family members

Keywords: diagnosis craniocerebral trauma pediatrics s100b mild traumatic brain injury