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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,209
Hospices Civils de LYON
Bron, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Limoges Teaching hospital
Limoges, France
Assistance Publique des Hôpitaux de Marseille
Marseille, France
Montpellier Teaching hopsital
Montpellier, France
Nantes Teaching Hospital
Nantes, France
Nice Teaching Hospital
Nice, France
Nimes Teaching Hospital
Nîmes, France
Reims Teaching Hospital
Reims, France
Saint-Etienne Teaching Hospital
Saint-Etienne, France
...and 1 more locations
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.
Time frame: at day 1
utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room
Time frame: at day 1
utility of serum S100B measurement with respect to reduction in the duration of hospitalization
Time frame: at day 1
utility of serum S100B measurement with respect to reduction in radiation exposure (mSv)
Time frame: 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)
Time frame: at day 1
utility of serum S100B measurement with respect to absence of intercurrent events at 48 hours and 3 weeks after mTBI
Time frame: at 48 hours and 3 weeks after mTBI
utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay
Time frame: at day 1
utility of serum S100B measurement with respect to reduction of the cost of management
Time frame: at day 1
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