Operation Allies Welcome Medical Response Unit at Philadelphia International Airport: A Framework for Medical Triage of High Volume of Displaced Persons Arriving by Air.

In the aftermath of the US withdrawal from Afghanistan, over 100,000 individuals were evacuated to the United States, primarily arriving through Philadelphia International Airport and Dulles International Airport under Operation Allies Welcome. In Philadelphia, evacuees were greeted at the airport by a medical triage unit (MTU) that was rapidly assembled to provide on-site medical care. The MTU triaged emergent medical complaints, handled minor complaints on-site to reduce impact on local health care systems, distributed patients who did require a higher level of care among area hospitals, and ensured appropriate follow-up care for individuals with ongoing needs. Although there are regional and federal entities whose purview is the establishment and coordination of such responses, these entities were not mobilized to respond immediately when planes began to arrive carrying the first wave of evacuees as this event was not a designated disaster. The MTU was a grassroots effort initiated by local health care providers in coordination with the local Medical Reserve Corps and Department of Public Health. This article presents a framework for similar operations, anticipating an ongoing need for planning for sudden arrivals of large numbers of displaced persons, particularly via air travel, in a time of increasing mass displacement events, as well as a rationale for establishing more robust networks of local medical professionals willing to respond in the case of an emergency and involving them in the emergency planning processes to ensure preexisting protocols are practical.

Transient albuminuria in the setting of short-term severe hyperglycemia in type 1 diabetes.

In a cohort of 1817 children with type 1 diabetes (T1D), short-term hyperglycemia was associated with transient albuminuria (11 % during new-onset T1D without diabetic ketoacidosis (DKA), 12 % during/after DKA, 6 % during routine screening). Our findings have implications regarding future risk of diabetic kidney disease and further investigation is needed.

Head Injury Treatment With Healthy and Advanced Dietary Supplements: A Pilot Randomized Controlled Trial of the Tolerability, Safety, and Efficacy of Branched Chain Amino Acids in the Treatment of Concussion in Adolescents and Young Adults.

Concussion is a common injury in the adolescent and young adult populations. Although branched chain amino acid (BCAA) supplementation has shown improvements in neurocognitive and sleep function in pre-clinical animal models of mild-to-moderate traumatic brain injury (TBI), to date, no studies have been performed evaluating the efficacy of BCAAs in concussed adolescents and young adults. The goal of this pilot trial was to determine the efficacy, tolerability, and safety of varied doses of oral BCAA supplementation in a group of concussed adolescents and young adults. The study was conducted as a pilot, double-blind, randomized controlled trial of participants ages 11-34 presenting with concussion to outpatient clinics (sports medicine and primary care), urgent care, and emergency departments of a tertiary care pediatric children's hospital and an urban tertiary care adult hospital, between June 24, 2014 and December 5, 2020. Participants were randomized to one of five study arms (placebo and 15 g, 30 g, 45 g, and 54 g BCAA treatment daily) and followed for 21 days after enrollment. Outcome measures included daily computerized neurocognitive tests (processing speed, the a priori primary outcome; and attention, visual learning, and working memory), symptom score, physical and cognitive activity, sleep/wake alterations, treatment compliance, and adverse events. In total, 42 participants were randomized, 38 of whom provided analyzable data. We found no difference in our primary outcome of processing speed between the arms; however, there was a significant reduction in total symptom score (decrease of 4.4 points on a 0-54 scale for every 500 g of study drug consumed, p value for trend = 0.0036, [uncorrected]) and return to physical activity (increase of 0.503 points on a 0-5 scale for every 500 g of study drug consumed, p value for trend = 0.005 [uncorrected]). There were no serious adverse events. Eight of 38 participants reported a mild (not interfering with daily activity) or moderate (limitation of daily activity) adverse event; there were no differences in adverse events by arm, with only two reported mild adverse events (both gastrointestinal) in the highest (45 g and 54 g) BCAA arms. Although limited by slow enrollment, small sample size, and missing data, this study provides the first demonstration of efficacy, as well as safety and tolerability, of BCAAs in concussed adolescents and young adults; specifically, a dose-response effect in reducing concussion symptoms and a return to baseline physical activity in those treated with higher total doses of BCAAs. These findings provide important preliminary data to inform a larger trial of BCAA therapy to expedite concussion recovery.

Custom injury prevention priority scoring: Local ranking procedures to assess unique community needs: Local Pediatric Injury Prevention Priority Scoring.

BACKGROUND: Trauma is the leading cause of morbidity and mortality in children. Many traumatic injuries are preventable and trauma centers play a major role in directing population-level injury prevention strategies. Given the constraint of finite resources, calculating priorities for injury prevention at an institutional level is essential. The Injury Prevention and Priority Score (IPPS) is a widely applicable tool that is more robust than simple prevalence rankings and considers injury severity - an important factor when developing prevention strategies. We developed an adapted-IPPS methodology to define our local injury prevention priorities using our institution's patient population. METHODS: The institution-specific trauma registry was used, which includes patients presenting to a level 1 pediatric trauma center July 2018 - June 2022. Causes of injury were categorized into injury mechanisms based on external cause codes. Mechanisms of injury were ranked by frequency and severity (based on mean Injury Severity Score, ISS). An IPPS was calculated for each of the injury mechanisms, which were then ranked from highest to lowest priority injury mechanism. RESULTS: In ranking injury mechanisms by IPPS, "falls" remain the top priority mechanism despite their relatively low severity, given their overwhelming frequency (n = 1993, mean ISS = 5.9). The injury mechanisms "motor vehicle" (n = 434, mean ISS = 10.9) and "pedestrian" (n = 13, mean ISS = 15), become higher priority given their injury severity, despite lower frequency. "Pedestrian" includes non-traffic incidents such as patients run over by cars in driveways or rural settings. CONCLUSIONS: Computing the IPPS for each injury mechanism, using data collected routinely for trauma registries, enables trauma centers to use local data to inform injury prevention efforts in their communities. Calculating rankings based on an injury mechanism's relative frequency and severity allows a more robust understanding of their impact. LEVEL OF EVIDENCE: IV.

Pediatric capacity crisis: A framework and strategies to prepare for a pediatric surge.

A pediatric capacity crisis developed across the country in the Fall and Winter of 2022 due to a combination of factors, including a surge in respiratory viruses, staffing shortages, and historical closures of inpatient pediatric units. The COVID-19 pandemic and associated surge in critically ill adult patients demonstrated that health care systems and health care workers can quickly implement creative and collaborative system-wide solutions to deliver the best care possible during a capacity crisis. Similar solutions are needed to respond to future surges in pediatric volume and to maintain a high standard of care during such a surge. This paper aims to build upon insights from the COVID-19 and H1N1 pandemic responses and the 2022 pediatric capacity crisis. We provide specific recommendations addressing governmental/policy, hospital/health care system, and individual clinician strategies that can be implemented to manage future surges in pediatric patient volume.

Changing The Playbook For Immigrant Health.

Philadelphia's response to welcoming Afghan evacuees during the COVID-19 pandemic suggests the need for a new approach to immigrant health care.

Rehydration Rates and Outcomes in Overweight Children With Diabetic Ketoacidosis.

BACKGROUND AND OBJECTIVES: The Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in Diabetic Ketoacidosis (DKA) (FLUID) Trial found that rapid fluid infusion does not increase the risk of cerebral injury. Concern persists, however, whether fluid rates should be adjusted for overweight or obese patients. We used the FLUID Trial database to evaluate associations between fluid infusion rate and outcomes in these patients. METHODS: We compared children and youth who were overweight, obese, or normal weight, in regard to protocol adherence, mental status changes, time to DKA resolution, and electrolyte abnormalities. We investigated associations between outcomes and the amount of fluid received in these groups. RESULTS: Obese children and youth were more likely to receive fluids at rates slower than dictated by protocol. Overweight and obese children and youth in the fast fluid arms, who received fluids per the study protocol based on their measured weight, had similar rates of mental status changes or clinically apparent cerebral injury as those with normal weights. Risk of hypophosphatemia was increased in those receiving larger initial bolus volumes and reduced in those receiving higher rehydration rates. No other metabolic outcomes were associated with rehydration. CONCLUSIONS: Protocol adherence data in the FLUID Trial suggest that physicians are uncomfortable using weight-based fluid calculations for overweight or obese children. However, higher rates of fluid infusion were not associated with increased risk of mental status changes or cerebral injury, suggesting that physicians should not limit fluid resuscitation in obese children and youth with DKA.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol.

INTRODUCTION: Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%-1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables. METHODS AND ANALYSIS: Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2-17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score<14, intoxication, known pregnancy, history of intracranial surgery, known structural abnormality of the brain, pre-existing condition predisposing to an intracranial abnormality or intracranial hypertension, head injury within 14 days or not speaking English or Spanish. Clinicians complete a standardised history and physical examination of all eligible patients. Primary outcome is the presence of an EIA as determined by neuroimaging or clinical follow-up. We will use binary recursive partitioning and multiple regression analyses to create and internally validate the risk stratification model. ETHICS AND DISSEMINATION: Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

Association between the presence of an advanced airway and ventilation rate during pediatric CPR: A report from the Videography in Pediatric Resuscitation (VIPER) collaborative.

OBJECTIVE: To determine the association between presence of an advanced airway during pediatric cardiopulmonary resuscitation (CPR) and ventilation rates. METHODS: Prospective observational study, January 2017 to June 2020. Patients ≤18 years receiving CC for ≥2 minutes were enrolled. Ventilation rate and type of airway (advanced airway (AA), either endotracheal tube (ETT) or supraglottic airway (SGA); or natural airway (NA)) were collected from video review and analyzed in 'CPR segments' (periods of CPR by individual providers). Ventilation rate (breaths per minute, bpm) was calculated for each segment; hyperventilation was defined as >12 bpm according to 2015 American Heart Association guidelines. Univariate analysis between airway type was done by χ2 testing. Multivariate regression was used to determine the association between the presence of AA with hyperventilation while controlling for within-patient covariance. RESULTS: 779 CPR segments from 94 CPR event were analyzed. The mean ventilation rate per CPR segment across all events was 22 bpm (±16 bpm)). Mean ventilation rates were higher with AA, either ETT (24 ± 17 bpm) or SGA (34 ± 19 bpm), than with NA (17 ± 14, p < 0.001). Hyperventilation occurred more often with AA in place (ETT: 68%; SGA: 96%; NA: 43%; p < 0.001). The presence of AA was independently associated with hyperventilation (AOR 9.3, 95% CI 4.3-20.1). CONCLUSIONS: During pediatric CPR, hyperventilation occurs more often with an AA in place than during CPR with NA. Future research should focus on respiratory physiology during pediatric CPR to determine optimal ventilation rate(s) during pediatric cardiac arrest.

Variability in firearm injury among major pediatric trauma centers across the USA.

Objectives: In 2020, firearm injuries surpassed automobile collisions as the leading cause of death in US children. Annual automobile fatalities have decreased during 40 years through a multipronged approach. To develop similarly targeted public health interventions to reduce firearm fatalities, there is a critical need to first characterize firearm injuries and their outcomes at a granular level. We sought to compare firearm injuries, outcomes, and types of shooters at trauma centers in four pediatric health systems across the USA. Methods: We retrospectively extracted data from each institution's trauma registry, paper and electronic health records. Study included all patients less than 19 years of age with a firearm injury between 2003 and 2018. Variables collected included demographics, intent, resources used, and emergency department and hospital disposition. Descriptive statistics were reported using medians and IQRs for continuous data and counts with percentages for categorical data. χ2 test or Fisher's exact test was conducted for categorical comparisons. Results: Our cohort (n=1008, median age 14 years) was predominantly black and male. During the study period, there was an overall increase in firearm injuries, driven primarily by increases in the South (S) site (ß=0.11 (SE 0.02), p=<0.001) in the setting of stable rates in the West and decreasing rates in the Northeast and Mid-Atlantic sites (ß=-0.15 (SE 0.04), p=0.002; ß=-0.19 (SE0.04), p=0.001). Child age, race, insurance type, resource use, injury type, and shooter type all varied by regional site. Conclusion: The incidence of firearm-related injuries seen at four sites during 15 years varied by site and region. The overall increase in firearm injuries was predominantly driven by the S site, where injuries were more often unintentional. This highlights the need for region-specific data to allow for the development of targeted interventions to impact the burden of injury.Level of Evidence: II, retrospective study.

Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial.

Importance: There is a paucity of pediatric-specific comparative data to guide duration of therapy recommendations in children with urinary tract infection (UTI). Objective: To compare the efficacy of standard-course and short-course therapy for children with UTI. Design, Setting, Participants: The Short Course Therapy for Urinary Tract Infections (SCOUT) randomized clinical noninferiority trial took place at outpatient clinics and emergency departments at 2 children's hospitals from May 2012, through, August 2019. Data were analyzed from January 2020, through, February 2023. Participants included children aged 2 months to 10 years with UTI exhibiting clinical improvement after 5 days of antimicrobials. Intervention: Another 5 days of antimicrobials (standard-course therapy) or 5 days of placebo (short-course therapy). Main Outcome Measures: The primary outcome, treatment failure, was defined as symptomatic UTI at or before the first follow-up visit (day 11 to 14). Secondary outcomes included UTI after the first follow-up visit, asymptomatic bacteriuria, positive urine culture, and gastrointestinal colonization with resistant organisms. Results: Analysis for the primary outcome included 664 randomized children (639 female [96%]; median age, 4 years). Among children evaluable for the primary outcome, 2 of 328 assigned to standard-course (0.6%) and 14 of 336 assigned to short-course (4.2%) had a treatment failure (absolute difference of 3.6% with upper bound 95% CI of 5.5.%). Children receiving short-course therapy were more likely to have asymptomatic bacteriuria or a positive urine culture at or by the first follow-up visit. There were no differences between groups in rates of UTI after the first follow-up visit, incidence of adverse events, or incidence of gastrointestinal colonization with resistant organisms. Conclusions and Relevance: In this randomized clinical trial, children assigned to standard-course therapy had lower rates of treatment failure than children assigned to short-course therapy. However, the low failure rate of short-course therapy suggests that it could be considered as a reasonable option for children exhibiting clinical improvement after 5 days of antimicrobial treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT01595529.

Clinical and Laboratory Predictors of Dehydration Severity in Children With Diabetic Ketoacidosis.

STUDY OBJECTIVE: Our primary objective was to characterize the degree of dehydration in children with diabetic ketoacidosis (DKA) and identify physical examination and biochemical factors associated with dehydration severity. Secondary objectives included describing relationships between dehydration severity and other clinical outcomes. METHODS: In this cohort study, we analyzed data from 753 children with 811 episodes of DKA in the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation Study, a randomized clinical trial of fluid resuscitation protocols for children with DKA. We used multivariable regression analyses to identify physical examination and biochemical factors associated with dehydration severity, and we described associations between dehydration severity and DKA outcomes. RESULTS: Mean dehydration was 5.7% (SD 3.6%). Mild (0 to <5%), moderate (5 to <10%), and severe (≥10%) dehydration were observed in 47% (N=379), 42% (N=343), and 11% (N=89) of episodes, respectively. In multivariable analyses, more severe dehydration was associated with new onset of diabetes, higher blood urea nitrogen, lower pH, higher anion gap, and diastolic hypertension. However, there was substantial overlap in these variables between dehydration groups. The mean length of hospital stay was longer for patients with moderate and severe dehydration, both in new onset and established diabetes. CONCLUSION: Most children with DKA have mild-to-moderate dehydration. Although biochemical measures were more closely associated with the severity of dehydration than clinical assessments, neither were sufficiently predictive to inform rehydration practice.

Trauma-informed and family-centered paediatric resuscitation: Defining domains and practices.

Aim: For paediatric patients and families, resuscitation can be an extremely stressful experience with significant medical and psychological consequences. Psychological sequelae may be reduced when healthcare teams apply patient- and family-centered care and trauma-informed care, yet there are few specific instructions for effective family-centered or trauma-informed behaviours that are observable and teachable. We aimed to develop a framework and tools to address this gap. Methods: We reviewed relevant policy statements, guidelines, and research to define core domains of family-centered and trauma-informed care, and identified observable evidence-based practices in each domain. We refined this list of practices via review of provider/team behaviours in simulated paediatric resuscitation scenarios, then developed and piloted an observational checklist. Results: Six domains were identified: (1) Sharing information with patient and family; (2) Promoting family involvement in care and decisions; (3) Addressing family needs and distress; (4) Addressing child distress; (5) Promoting effective emotional support for child; (6) Practicing developmental and cultural competence. A 71-item observational checklist assessing these domains was feasible for use during video review of paediatric resuscitation. Conclusion: This framework can guide future research and provide tools for training and implementation efforts to improve patient outcomes through patient- and family-centered and trauma-informed care.

Cognitive function following diabetic ketoacidosis in young children with type 1 diabetes.

INTRODUCTION: Young children with type 1 diabetes (T1D) may be at particularly high risk of cognitive decline following diabetic ketoacidosis (DKA). However, studies of cognitive functioning in T1D typically examine school-age children. The goal of this study was to examine whether a single experience of DKA is associated with lower cognitive functioning in young children. We found that recently diagnosed 3- to 5-year-olds who experienced one DKA episode, regardless of its severity, exhibited lower IQ scores than those with no DKA exposure. METHODS: We prospectively enrolled 46 3- to 5-year-old children, who presented with DKA at the onset of T1D, in a randomized multi-site clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 22 children and mild in 24 children. Neurocognitive function was assessed once 2-6 months after the DKA episode. A comparison group of 27 children with T1D, but no DKA exposure, was also assessed. Patient groups were matched for age and T1D duration at the time of neurocognitive testing. RESULTS: Children who experienced DKA, regardless of its severity, exhibited significantly lower IQ scores than children who did not experience DKA, F(2, 70) = 6.26, p = .003, partial η2  = .15. This effect persisted after accounting for socioeconomic status and ethnicity. CONCLUSIONS: A single DKA episode is associated with lower IQ scores soon after exposure to DKA in young children.

The effect of hand position on chest compression quality during CPR in young children: Findings from the Videography in Pediatric Resuscitation (VIPER) collaborative.

OBJECTIVE: To determine the effect of hand position on chest compression (CC) quality during CPR in young children. METHODS: Prospective observational exploratory study. Patients < 8 years receiving CC for > 2 minutes were enrolled. Data was collected from video review and CC monitor device and analyzed in 'CC segments' (periods of CC by individual providers). Four techniques were compared: two thumbs (2 T), hands encircling the chest; two fingers (2F) on the sternum; one hand on sternum (1H); two hands on sternum (2H). Univariate analysis of CC rate and depth between hand positions was performed through nonparametric testing, stratified by age category. RESULTS: 47 patients received 824 minutes of CC. Among 270 CC segments in infants < 1 yo, 2 T was used in 27%; 2F 3%; 1H 18%; 2H 26%. Among 189 CC segments in children aged 1 to 8 yo, 1H was used in 26%; 2H 74%. Across all segments, median CC rate was 117 cpm (IQR 110-125). Median depth was 2.92 cm (IQR 2.44 - 4.04) in infants < 1 yo, 3.56 cm (IQR 2.92 - 4.14) in children 1 to 8 yo. 1H achieved greater depth than 2 T in infants (p < 0.01), and 2H achieved greater depth than 1H in children > 1 (p < 0.001). CONCLUSIONS: In infants, 1H resulted in greater CC depth than 2 T. In children 1 to 8 yo, 2H resulted in greater depth than 1H.. These data suggest that different hand position during CPR in young children from what is currently recommended may result in better CPR quality.

Relationships among biochemical measures in children with diabetic ketoacidosis.

OBJECTIVES: Investigating empirical relationships among laboratory measures in children with diabetic ketoacidosis (DKA) can provide insights into physiological alterations occurring during DKA. We determined whether alterations in laboratory measures during DKA conform to theoretical predictions. METHODS: We used Pearson correlation statistics and linear regression to investigate correlations between blood glucose, electrolytes, pH and PCO2 at emergency department presentation in 1,681 pediatric DKA episodes. Among children with repeat DKA episodes, we also assessed correlations between laboratory measures at the first vs. second episode. RESULTS: pH and bicarbonate levels were strongly correlated (r=0.64), however, pH and PCO2 were only loosely correlated (r=0.17). Glucose levels were correlated with indicators of dehydration and kidney function (blood urea nitrogen (BUN), r=0.44; creatinine, r=0.42; glucose-corrected sodium, r=0.32). Among children with repeat DKA episodes, PCO2 levels tended to be similar at the first vs. second episode (r=0.34), although pH levels were only loosely correlated (r=0.19). CONCLUSIONS: Elevated glucose levels at DKA presentation largely reflect alterations in glomerular filtration rate. pH and PCO2 are weakly correlated suggesting that respiratory responses to acidosis vary among individuals and may be influenced by pulmonary and central nervous system effects of DKA.

Pyuria in Children with Diabetic Ketoacidosis.

Acute kidney injury occurs frequently during pediatric diabetic ketoacidosis (DKA). We reviewed urinalyses from 561 children with DKA; pyuria was detected in 19% overall and in 40% of children with more comprehensive urine testing (≥3 urinalyses) during DKA.

Clinical Characteristics of Children with Cerebral Injury preceding Treatment of Diabetic Ketoacidosis.

Previous studies have identified more severe acidosis and higher blood urea nitrogen (BUN) as risk factors for cerebral injury during treatment of diabetic ketoacidosis (DKA) in children; however, cerebral injury also can occur before DKA treatment. We found that lower pH and higher BUN levels also were associated with cerebral injury at presentation.

Pediatric Septic Shock Collaborative Improves Emergency Department Sepsis Care in Children.

OBJECTIVES: The pediatric emergency department (ED)-based Pediatric Septic Shock Collaborative (PSSC) aimed to improve mortality and key care processes among children with presumed septic shock. METHODS: This was a multicenter learning and improvement collaborative of 19 pediatric EDs from November 2013 to May 2016 with shared screening and patient identification recommendations, bundles of care, and educational materials. Process metrics included minutes to initial vital sign assessment and to first and third fluid bolus and antibiotic administration. Outcomes included 3- and 30-day all-cause in-hospital mortality, hospital and ICU lengths of stay, hours on increased ventilation (including new and increases from chronic baseline in invasive and noninvasive ventilation), and hours on vasoactive agent support. Analysis used statistical process control charts and included both the overall sample and an ICU subgroup. RESULTS: Process improvements were noted in timely vital sign assessment and receipt of antibiotics in the overall group. Timely first bolus and antibiotics improved in the ICU subgroup. There was a decrease in 30-day all-cause in-hospital mortality in the overall sample. CONCLUSIONS: A multicenter pediatric ED improvement collaborative showed improvement in key processes for early sepsis management and demonstrated that a bundled quality improvement-focused approach to sepsis management can be effective in improving care.

Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): a pilot randomized trial.

BACKGROUND: The antifibrinolytic drug tranexamic acid (TXA) improves survival in adults with traumatic hemorrhage; however, the drug has not been evaluated in a trial in injured children. We evaluated the feasibility of a large-scale trial evaluating the effects of TXA in children with severe hemorrhagic injuries. METHODS: Severely injured children (0 up to 18th birthday) were randomized into a double-blind randomized trial of 1) TXA 15 mg/kg bolus dose, followed by 2 mg/kg/hr infusion over 8 hours, 2) TXA 30 mg/kg bolus dose, followed by 4 mg/kg/hr infusion over 8 hours, or 3) normal saline placebo bolus and infusion. The trial was conducted at 4 pediatric Level I trauma centers in the United States between June 2018 and March 2020. We enrolled patients under federal exception from informed consent (EFIC) procedures when parents were unable to provide informed consent. Feasibility outcomes included the rate of enrollment, adherence to intervention arms, and ability to measure the primary clinical outcome. Clinical outcomes included global functioning (primary), working memory, total amount of blood products transfused, intracranial hemorrhage progression, and adverse events. The target enrollment rate was at least 1.25 patients per site per month. RESULTS: A total of 31 patients were randomized with a mean age of 10.7 years (standard deviation [SD] 5.0 years) and 22 (71%) patients were male. The mean time from injury to randomization was 2.4 hours (SD 0.6 hours). Sixteen (52%) patients had isolated brain injuries and 15 (48%) patients had isolated torso injuries. The enrollment rate using EFIC was 1.34 patients per site per month. All eligible enrolled patients received study intervention (9 patients TXA 15 mg/kg bolus dose, 10 patients TXA 30 mg/kg bolus dose, and 12 patients placebo) and had the primary outcome measured. No statistically significant differences in any of the clinical outcomes were identified. CONCLUSION: Based on enrollment rate, protocol adherence, and measurement of the primary outcome in this pilot trial, we confirmed the feasibility of conducting a large-scale, randomized trial evaluating the efficacy of TXA in severely injured children with hemorrhagic brain and/or torso injuries using EFIC.