Pediatrics Clinical Trial
— PROS100BOfficial title:
Interventional Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
Verified date | May 2022 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2209 |
Est. completion date | May 31, 2022 |
Est. primary completion date | December 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 | Nimes | |
France | Reims Teaching Hospital | Reims | |
France | Saint-Etienne Teaching Hospital | Saint-Etienne | |
France | Vichy Hospital Center | Vichy |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Bouvier D, Fournier M, Dauphin JB, Amat F, Ughetto S, Labbe A, Sapin V. Serum S100B determination in the management of pediatric mild traumatic brain injury. Clin Chem. 2012 Jul;58(7):1116-22. doi: 10.1373/clinchem.2011.180828. Epub 2012 Apr 23. — View Citation
The management of minor closed head injury in children. Committee on Quality Improvement, American Academy of Pediatrics. Commission on Clinical Policies and Research, American Academy of Family Physicians. Pediatrics. 1999 Dec;104(6):1407-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | utility of serum S100B measurement with respect to reduction in the time spent in the pediatric emergency room | at day 1 | ||
Secondary | utility of serum S100B measurement with respect to reduction in the duration of hospitalization | at day 1 | ||
Secondary | utility of serum S100B measurement with respect to reduction in radiation exposure (mSv) | at day 1 | ||
Secondary | 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 | |
Secondary | 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 | ||
Secondary | utility of serum S100B measurement with respect to compliance of emergency physicians with the S100B assay | at day 1 | ||
Secondary | utility of serum S100B measurement with respect to reduction of the cost of management | at day 1 |
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