Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

Conditions
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Craniocerebral Trauma, Pediatrics

Intervention / Treatment
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* Procedure: usual care
* Procedure: S100B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>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 | Procedure: usual care<br> <br> |
| Other: interventional group<br>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 | Procedure: S100B<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| utility of serum S100B measurement in the management of pediatric mTBI | Evaluate the utility of serum S100B measurement in the management of pediatric mTBI by demonstrating a decrease in the proportion of CCT-scan prescribed in the S100B management intervention arm compared with the conventional management control arm, hypothesizing a 30% decrease in the number of CCT-scan between the intervention versus control arms. | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room |  | at day 1 | 
| utility of serum S100B measurement with respect to reduction in the duration of hospitalization |  | at day 1 | 
| utility of serum S100B measurement with respect to reduction in radiation exposure (mSv) |  | at day 1 | 
| utility of serum S100B measurement with respect to detection of complications | detection of complications (intracranial lesions) by CCT-scan which can occur at a rate of 0-7% in patients with mTBI (American Academy of Pediatrics, 1999) | at day 1 | 
| utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI |  | at 48 hours and 3 weeks after mTBI | 
| utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay |  | at day 1 | 
| utility of serum S100B measurement with respect to reduction of the cost of management |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury