Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury (PROS100B)
Craniocerebral Trauma, Pediatrics
About this trial
This is an interventional diagnostic trial for Craniocerebral Trauma focused on measuring Diagnosis, Craniocerebral Trauma, Pediatrics, S100B, mild traumatic brain injury
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
Sites / Locations
- Hospices Civils de LYON
- CHU Clermont-Ferrand
- Limoges Teaching hospital
- Assistance Publique des Hôpitaux de Marseille
- Montpellier Teaching hopsital
- Nantes Teaching Hospital
- Nice Teaching Hospital
- Nimes Teaching Hospital
- Reims Teaching Hospital
- Saint-Etienne Teaching Hospital
- Vichy Hospital Center
Arms of the Study
Arm 1
Arm 2
Other
Other
Control group
interventional group
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
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