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Randomized Controlled Trial
. 2024 Mar 4;7(3):e242366.
doi: 10.1001/jamanetworkopen.2024.2366.

Serum S100B Level in the Management of Pediatric Minor Head Trauma: A Randomized Clinical Trial

Damien Bouvier  1 , Aymeric Cantais  2 , Alban Laspougeas  3 , Fleur Lorton  4 , Yannick Plenier  5 , Maria Cottier  6 , Philippe Fournier  7 , Antoine Tran  8 , Emilie Moreau  9 , Julie Durif  10 , Catherine Sarret  11 , Charline Mourgues  12 , Franck Sturtz  13 , Jean-Baptiste Oudart  14 , Juliette Raffort  15 , Philippe Gonzalo  16 , Jean-Paul Cristol  17 , Damien Masson  18 , Bruno Pereira  12 , Vincent Sapin  1
Affiliations
Randomized Controlled Trial

Serum S100B Level in the Management of Pediatric Minor Head Trauma: A Randomized Clinical Trial

Damien Bouvier et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

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.

Figures

Figure.
Figure.. Study Flowchart
GCS indicates Glasgow Coma Scale; HT, head trauma.
See this image and copyright information in PMC

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