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TOPLINE:  Serum S100B level monitoring does not reduce cranial CT (CCT) scan recommendations in children with mild head trauma; however, a post hoc analysis involving only centers that followed a clinical decision algorithm showed a significant reduction in CCT scan recommendations.

METHODOLOGY:

• In this multicenter randomized clinical trial, 2078 children (median age, 3.2 years; 59.4% boys) with minor head trauma admitted to emergency departments were randomly assigned to biomonitoring, including the S100B protein assay as part of the treatment, or conventional treatment groups.
• The primary endpoint was the proportion of CCT scans recommended within 48 hours of head trauma.
• The secondary endpoints included duration of hospitalization, cost of hospitalization, effective radiation dose for each CCT scan recorded on each patient's X-ray report, presence of intracranial injury on CCT scans, and presence of persistent clinical signs at the telephone follow-up interviews, among others.

• 32.3% of children in the control group and 9.7% of those in the S100B biomonitoring group underwent a CCT scan; this difference was not statistically significant (P = .44).
• In a post hoc analysis of four centers that followed a clinical decision algorithm, a significant reduction in CCT scan recommendations was noted in the S100B biomonitoring group (absolute risk reduction, 0.49; P = .002).
• Compared with the control group, the S100B biomonitoring group showed a significant reduction in hospitalizations for monitoring (relative risk [RR], 0.46; P < .001) and median cost of hospitalization (RR, −213 €; P < .001).
• No differences were noted in the intracranial injuries on the first scan or persistent clinical signs in the follow-up telephone interview.
• The effective radiation dose was higher in the biomonitoring group (P = .01) than in the control group.

IN PRACTICE:

Based on the results of the post hoc analysis, the authors wrote, "societies in pediatrics and emergency medicine could issue recommendations along these lines."

SOURCE:

The study was conducted by Damien Bouvier, MD, PhD, Department of Biochemistry and Molecular Genetics, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France, and published online in JAMA Network Open. 

LIMITATIONS:

The enrollment of centers into the two groups was challenging. CCT scans between centers showed high variability. In addition, some centers stopped enrollment during the changeover. An independent committee decided to halt the trial and conduct a post hoc exploratory analysis.

DISCLOSURES:

The study received support from the French Ministry of Health. One author reported receiving nonfinancial support and personal fees from Novartis AG, Lupin, PTC Therapeutics, Orchard Therapeutics, argenx, and Egetis Therapeutics AB. Other authors declared no conflicts of interest.