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Serum S100B Level in the Management of Paediatric Minor Head Trauma
Estimated Read Time: 8 minutes, 44 seconds
Originally Published: 19 March 2024
Source: JAMA Network Open
Type of article: Clinical Research Summary
MedED Catalogue Reference:MPC0012
Category: Paediatrics & Neonatology
Cross-reference: Emergency Medicine, Critical Care, Neurology
Keywords:S100B biomonitoring, CCT, Biomarkers, Head Injury
Originally Published in The Lancet 19 March 2024, reproduced under CC-BY-LICENCE. This is a summary of the clinical study and in no way represents the original research. Links to all original material can be found in the body of this summary.
Key Take Aways
1. Evaluating serum S100B biomonitoring in minor head trauma management presents a promising avenue for paediatricians, potentially reducing the need for cranial computed tomography (CCT) scans.
2. In this study, a significant reduction in CCT scans within 48 hours of minor Head Trauma was observed when serum S100B biomonitoring was implemented
3. Where children were hospitalised, there was a statistically significant decrease in stays of longer than 48 hours, which was associated with cost savings
5. The results show that Serum S100 B biomonitoring has the potential to streamline diagnostic practices and minimize radiation exposure in paediatric patients presenting with head trauma.
Overview | Objectives | Study Design | Findings | Discussion| Limitations | Conclusion | Original Research | Funding
Overview
Head trauma (HT) in children poses a significant public healthcare concern. Mild head trauma, in particular, accounts for a significant number of paediatric hospital admissions.
While CCT scans are standard practice for adults experiencing head trauma (HT), recent large epidemiological studies have revealed an elevated risk of cancer associated with radiation exposure in young children. In response, clinical decision rules have been developed to guide the appropriate utilization of CCT scans in this population group.
The Paediatric Emergency Care Applied Research Network algorithm categorizes children with minor head trauma into three risk groups—very low, intermediate, and high—based on Glasgow Coma Scale scores. This algorithm reportedly reduces the use of CCT scans by 10% across all risk categories. However, there are no specific observation guidelines for children in the intermediate-risk group, which encompasses approximately 30% of all children. In this group, observation alone or in conjunction with CCT scans is recommended without further defining observation.
Although a diagnostic test for HT involves blood sampling, it would prevent unnecessary hospitalizations and CCT scans for many children. The efficacy of Serum S100B, an acute HT biomarker, has been established in adult populations. However, further studies were required to standardize the interpretation of serum S100B values in the paediatric population using specific reference ranges.
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Objectives
The researchers of this study, Bouvier & Cantais et al., sought to address this research need in this study by assessing the impact of serum S100B measurement on reducing CCT recommendations in paediatric minor HT cases.
Their secondary objectives included evaluating its effects on emergency department stays hospitalizations, radiation exposure, complication detection, absence of adverse effects, and cost reduction.
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Study Design & Methods
Study Design
This multicenter, unblinded, prospective, interventional randomized clinical trial used a stepped-wedge cluster design to compare S100B biomonitoring and control groups at 11 centres in France.
Intervention
A total of 2078 children were included: 926 in the control group and 1152 in the S100B biomonitoring group.
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. Where that was not the case, children were treated as in the control group
Inclusion Criteria
- For children who were younger than 2 years, the criteria were parietal or occipital scalp hematoma, loss of consciousness for more than 5 seconds, trauma due to a severe accident and abnormal behaviour as reported by the parents.
- For children 2 years and older, the criteria were loss of consciousness at the time of the accident, vomiting, trauma due to severe accident and severe headache
Exclusion Criteria
Children were excluded from the study in the following instances:
- Trauma occurring more than 3 hours prior to admission, a GCS score of 13 or 14, signs of skull fracture or skull base lesions (CCT scan recommended),
- HT that did not require either hospitalization or a CCT scan or both as per SFP recommendations
- Enrollment in another therapeutic trial with drug administration, Down syndrome, melanoma,
- Refusal by the child, parents, or legal guardian
Outcome Measures
The primary endpoint was the proportion of CCT scans recommended (absence or presence of CCT scan for each patient) within 48 hours of HT, compared between the 2 groups.
- The duration of management, defined as the time spent in the paediatric emergency department from admission to discharge
- The duration of hospitalization for observation and the associated costs.
- The effective radiation dose for each CCT scan; the identification of intracranial injuries on CCT scans via radiological examination,
- The presence of persistent clinical signs during telephone follow-up interviews conducted 48 hours and three weeks post-injury.
- For discharged patients, the assessment of clinical signs at 48 hours and then 3 weeks post-injury was conducted through standardized telephone interviews administered by a clinical research associate.
- For patients who had been hospitalised, follow-up was conducted using medical records. Clinical signs evaluated included vomiting, facial paralysis, movement disorders, vertigo, pupillary light reflex disorder, seizure, progressive headache, or behaviour change. Admission to ICU or neurology units was noted
- 0 to 9 months, greater than 0.35 μg/L;
- 10 to 24 months, greater than 0.23 μg/L; and
- older than 24 months, greater than 0.18 μg/L.3
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.
Findings
Of the 2078 children included in the study:
- 926 were included in the control group
- 1152 in the S100B biomonitoring group
- 1235 were boys [59.4%]
- And the median age was 3.2 [IQR, 1.0-8.5] years
A CCT scan was performed for 299 children (32.3%) in the control group and 112 in the S100B biomonitoring group (9.7%)
- This difference of 23% (95% CI, 19%-26%) was not statistically significant
- 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).
- A statistically significant reduction of hospitalizations 479 [41.6%] vs 849 [91.7%]
- A reduction in hospitalisation longer than 48 hours (50 [4.3%] vs 55 [5.9%] in the control group
- A reduction in mean hospitalisation cost: €181 vs €498
- 1018 children were included: 261 in the control group and 757 in the S100B biomonitoring group
- The post hoc analysis highlighted a significant reduction in CCT scan recommendations in the S100B biomonitoring group when compared with the control group (ARR, 0.49 [95% CI, 0.30-0.77]; P = .002)
Discussion
Adjusting for age and causes of minor HT, they found that 32.3% of control group children underwent CCT scans within 48 hours, compared to 9.7% in the S100B biomonitoring group. However, this reduction wasn't significant due to intercenter variability and enrollment cessation at some centres. Improving physician familiarity with the biomarker could enhance protocol adherence and accurately gauge S100B's effectiveness.
In the exploratory post hoc analysis across four observant centres, compliance with the decision algorithm revealed that 7.7% of children in the control group underwent CCT scans within 48 hours of minor head trauma, compared to 4.1% in the S100B biomonitoring group, a statistically significant reduction without significant centre effects. Additionally, hospitalization rates differed significantly, with 91.7% of control group children hospitalized for monitoring compared to 41.6% in the S100B biomonitoring group, reflecting variations between French and North American recommendations regarding monitoring durations.
A meta-analysis underscored the need for a large multicenter study in paediatric populations while utilizing age-adjusted reference ranges. Following the implementation of a modified Paediatric Emergency Care Applied Research Network rule with S100B assay, a before-and-after study in 1062 children at intermediate risk of clinically important traumatic brain injury revealed significant reductions in CCT scans (34%, 95% CI: 10.3%-54.6%) and in-hospital observations (45.2%, 95% CI: 39.9%-51.3%).
In their analysis, they found a relative risk (RR) of 0.49 (95% CI: 0.30-0.77) for CCT scans in the post hoc analysis and 0.46 (95% CI: 0.39-0.51) for in-hospital observations in the modified intention-to-treat analysis.
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Limitations
The study faced limitations regarding enrollment difficulties across centres, a common challenge in emergency settings involving pediatric populations.
A prespecified interim analysis conducted after enrolling 2000 patients highlighted the impact of the centre effect on the primary endpoint.Consequently, the independent committee opted to halt the trial and conduct a post hoc exploratory analysis to further investigate these findings.
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Conclusion
The researchers conclude that thier research showed that S100B measurement according to a defined clinical decision algorithm led to reduced rates of CCT scans and in-hospital observations, which may inform treatment protocols moving forward.
Access the original research
Bouvier D, Cantais A, Laspougeas A, et al. Serum S100B Level in the Management of Paediatric Minor Head Trauma: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(3):e242366. doi:10.1001/jamanetworkopen.2024.2366
Reproduced under CC BY License
Conflict of Interest, Funding and Support
ClinicalTrials.gov Identifier: NCT02819778
Conflict of Interest Disclosures:
Dr Sarret reported receiving nonfinancial support from Novartis AG, Lupin Limited, and PTC Therapeutics and personal fees from Orchard Therapeutics, argenx, and Egetis Therapeutics AB outside the submitted work. No other disclosures were reported.
Funding/Support:
This study was supported by grant PHRC-15-188 from the French Ministry of Health
Role of the Funder/Sponsor:
The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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