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Serum S100B Level in the Management of Pediatric Minor Head Trauma: A Randomized Clinical Trial
Damien Bouvier1, Aymeric Cantais2, Alban Laspougeas3
1Department of Biochemistry and Molecular Genetics, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Université Clermont Auvergne, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Génétique, Reproduction et Développement, Clermont-Ferrand, France.
Insights
Serum S100B testing can reduce cranial computed tomographic (CCT) scans and hospitalizations in children with minor head trauma (HT). This biomonitoring approach aids in managing pediatric head injuries more efficiently.
Area of Science:
- Pediatric Emergency Medicine
- Biomarkers
- Clinical Trials
Background:
- Minor head trauma (HT) is a frequent cause of pediatric hospitalization.
- Cranial computed tomographic (CCT) scans and hospital observation are often employed but may be unnecessary.
- A diagnostic tool could optimize management and reduce healthcare burden.
Purpose of the Study:
- To assess the efficacy of serum S100B levels in decreasing CCT scans and hospitalizations for children with minor HT.
- To evaluate the clinical utility of S100B biomonitoring in pediatric head injury management.
Main Methods:
- A multicenter, randomized clinical trial with a stepped-wedge cluster design.
- Comparison of S100B biomonitoring group versus a control group at 11 French centers.
- Children with minor HT managed based on serum S100B levels or standard recommendations.
Main Results:
- 2078 children were included; 1152 in the S100B group and 926 in the control group.
- A statistically significant 50% reduction in hospitalizations was observed in the S100B group (41.6% vs 91.7%).
- While CCT scan rates decreased in the S100B group (9.7% vs 32.3%), the difference was not statistically significant due to study design.
Conclusions:
- Serum S100B biomonitoring effectively reduces hospitalizations in children with minor head trauma.
- The use of a clinical decision algorithm based on S100B levels can guide management and decrease unnecessary interventions.
- S100B testing shows promise as a tool to optimize care for pediatric head injuries.
Importance:
Minor head trauma (HT) is one of the most common causes of hospitalization in children. A diagnostic test could prevent unnecessary hospitalizations and cranial computed tomographic (CCT) scans.
Objective:
To evaluate the effectiveness of serum S100B values in reducing exposure to CCT scans and in-hospital observation in children with minor HT.
Design, Setting, And Participants:
This multicenter, unblinded, prospective, interventional randomized clinical trial used a stepped-wedge cluster design to compare S100B biomonitoring and control groups at 11 centers in France. Participants included children and adolescents 16 years or younger (hereinafter referred to as children) admitted to the emergency department with minor HT. The enrollment period was November 1, 2016, to October 31, 2021, with a follow-up period of 1 month for each patient. Data were analyzed from March 7 to May 29, 2023, based on the modified intention-to-treat and per protocol populations.
Interventions:
Children in the control group had CCT scans or were hospitalized according to current recommendations. In the S100B biomonitoring group, blood sampling took place within 3 hours after minor HT, and management depended on serum S100B protein levels. If the S100B level was within the reference range according to age, the children were discharged from the emergency department. Otherwise, children were treated as in the control group.
Main Outcomes And Measures:
Proportion of CCT scans performed (absence or presence of CCT scan for each patient) in the 48 hours following minor HT.
Results:
A total of 2078 children were included: 926 in the control group and 1152 in the S100B biomonitoring group (1235 [59.4%] boys; median age, 3.2 [IQR, 1.0-8.5] years). Cranial CT scans were performed in 299 children (32.3%) in the control group and 112 (9.7%) in the S100B biomonitoring group. This difference of 23% (95% CI, 19%-26%) was not statistically significant (P = .44) due to an intraclass correlation coefficient of 0.32. A statistically significant 50% reduction in hospitalizations (95% CI, 47%-53%) was observed in the S100B biomonitoring group (479 [41.6%] vs 849 [91.7%]; P < .001).
Conclusions And Relevance:
In this randomized clinical trial of effectiveness of the serum S100B level in the management of pediatric minor HT, S100B biomonitoring yielded a reduction in the number of CCT scans and in-hospital observation when measured in accordance with the conditions defined by a clinical decision algorithm.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02819778.
