<p><strong>INTRODUCTION: </strong>We sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury.</p>

<p><strong>METHODS: </strong>Eligible patients were those &lt;18 years old who were admitted to the emergency department at three academic children's hospitals with head trauma and who received a clinically indicated head computed tomography (HCT). Measurements were obtained by a blinded operator in bilateral frontal, temporal, parietal, and occipital regions. Qualifying hematomas were a priori determined to be within the brain scanner's detection limits of &gt;3.5 milliliters in volume and &lt;2.5 centimeters from the surface of the brain. The device's measurements were positive if the difference in optical density between hemispheres was &gt;0.2 on three successive scans. We calculated diagnostic performance measures with corresponding exact two-sided 95% Clopper-Pearson confidence intervals (CI). Hypothesis test evaluated whether predictive performance exceeded chance agreement (predictive Youden's index &gt; 0).</p>

<p><strong>RESULTS: </strong>A total of 464 patients were enrolled and 344 met inclusion for primary data analysis: 10.5% (36/344) had evidence of a hematoma on HCT, and 4.7% (16/344) had qualifying hematomas. The handheld brain scanner demonstrated a sensitivity of 58.3% (21/36) and specificity of 67.9% (209/308) for hematomas of any size. For qualifying hematomas the scanner was designed to detect, sensitivity was 81% (13/16) and specificity was 67.4% (221/328). Predictive performance exceeded chance agreement with a predictive Youden's index of 0.11 (95% CI, 0.10 - 0.15; P &lt; 0.001) for all hematomas, and 0.09 (95% CI, 0.08 - 0.12; P &lt; 0.001) for qualifying hematomas.</p>

<p><strong>CONCLUSION: </strong>The handheld brain scanner can non-invasively detect a subset of intracranial hematomas in children and may serve an adjunctive role to head-injury neuroimaging decision rules that predict the risk of clinically significant intracranial pathology after head trauma.</p>

<p><strong>BACKGROUND: </strong>Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.</p>

<p><strong>METHODS: </strong>Open-label pragmatic randomized controlled trial (RCT) at a single academic children's hospital from January - August 2018. Eligible patients were &gt;6 months to &lt;18 years-old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.</p>

<p><strong>RESULTS: </strong>Of 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median crystalloid fluid volume received during the intervention window was 107 (IQR 60, 155) mL/kg and 98 (IQR 63, 128) mL/kg in the LR and NS arms, respectively (p=0.50). Patients randomized to LR received a median of only 20% (IQR 13, 32) of all study fluid as NS compared to 99% (IQR 64,100%) of study fluid as NS in the NS arm (absolute difference 79%, 95% CI 48,85).</p>

<p><strong>CONCLUSIONS: </strong>A pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock. This article is protected by copyright. All rights reserved.</p>