Intracranial Traumatic Hematoma Detection in Children Using a Portable Near-infrared Spectroscopy Device.

INTRODUCTION: We sought to validate a handheld, near-infrared spectroscopy (NIRS) device for detecting intracranial hematomas in children with head injury. METHODS: Eligible patients were those <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 >3.5 milliliters in volume and <2.5 centimeters from the surface of the brain. The device's measurements were positive if the difference in optical density between hemispheres was >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 > 0). RESULTS: 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 < 0.001) for all hematomas, and 0.09 (95% CI, 0.08 - 0.12; P < 0.001) for qualifying hematomas. CONCLUSION: 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.

Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis.

OBJECTIVES: To characterise current COVID-19-related research activities. DESIGN: Cross-sectional analysis. SETTING: Clinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19. DATA SOURCES: ClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic. MAIN OUTCOME MEASURES: We classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date. RESULTS: Of the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020. CONCLUSIONS: These findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study.

BACKGROUND: 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. METHODS: Open-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <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. RESULTS: 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 (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%). CONCLUSIONS: A pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.

Ultrasonographic Guidance to Improve First-Attempt Success in Children With Predicted Difficult Intravenous Access in the Emergency Department: A Randomized Controlled Trial.

STUDY OBJECTIVE: We determine whether ultrasonographically guided intravenous line placement improves the rate of first-attempt success by 20% for children with predicted difficult intravenous access. Secondary objectives included determining whether ultrasonographically guided intravenous line placement reduces the attempt number, improves time to access or parental satisfaction, or affects intravenous line survival and complications. METHODS: This was a prospective, randomized controlled trial conducted in an urban tertiary care pediatric emergency department that enrolled a convenience sample of children requiring an intravenous line and who were predicted to have difficult intravenous access according to a previously validated score. Participants were randomized to traditional or ultrasonographically guided intravenous line placement on first attempt and stratified by aged 0 to 3 versus older than 3 years. RESULTS: One hundred sixty-seven patients were enrolled and randomized to traditional intravenous line or to a care bundle with a multidisciplinary team trained to place ultrasonographically guided intravenous lines. First-attempt success was increased in the ultrasonographically guided intravenous line placement arm (n=83) compared with the traditional intravenous line arm (n=84) (85.4% versus 45.8%; relative risk 1.9; 95% confidence interval [CI] 1.5 to 2.4). There were fewer attempts in the ultrasonographically guided intravenous line placement arm than in the traditional intravenous line arm (median 1 versus 2; median difference 1; 95% CI 0.8 to 1.2) and a shorter time from randomization to intravenous line flush (median 14 minutes [interquartile range 11 to 20] versus 28 minutes [interquartile range 16 to 42]). A Kaplan-Meier survival analysis demonstrated that ultrasonographically guided intravenous lines survived longer than traditional ones (median 7.3 days [95% CI 3.7 to 9.5] versus 2.3 days [95% CI 1.8 to 3.3]). There was no difference in complications between the groups. Parents were more satisfied with ultrasonographically guided intravenous line placement. CONCLUSION: Ultrasonographically guided intravenous line placement in children with predicted difficult intravenous access improved first-attempt success and intravenous line longevity when conducted by a team of trained providers.

Identification of Optic Nerve Swelling Using Point-of-Care Ocular Ultrasound in Children.

OBJECTIVE: The aim of this study was to determine the feasibility and accuracy of point-of-care (POC) ocular ultrasound (US) when performed by a pediatric emergency medicine (PEM) physician to detect optic nerve abnormalities concerning for swelling, as compared with the fundus examination performed by an ophthalmologist. METHODS: This was a single-center, prospective cohort pilot study of children aged 12 months to 18 years who required optic disc evaluation by an ophthalmologist. Eligible subjects were enrolled from the emergency department, inpatient wards, and neuro-ophthalmology outpatient clinic of an urban, tertiary care children's hospital. Point-of-care ocular US, specifically assessing optic nerve sheath diameter and optic disc elevation, was performed. Findings on US were compared with findings identified by an ophthalmologist on dilated fundus examination. RESULTS: Seventy-six subjects were enrolled; 20 (26%) of 76 had findings concerning for optic nerve swelling diagnosed by an ophthalmologist on fundus examination. Using a sonographic definition for optic nerve swelling of optic nerve sheath diameter greater than 4.5 mm or the presence of optic disc elevation, the sensitivity and specificity were 90% and 55%, respectively. The success rate of POC ocular US was 100%, and the mean time to completion was 8 minutes. For emergency department subjects in whom direct fundus examination was attempted, the PEM physician could visualize the optic disc and assess for swelling in only 40% (14/35) of examinations. CONCLUSIONS: The results of our study suggest that POC ocular US performed by PEM physicians was feasible and determined to be sensitive but nonspecific in the detection of optic nerve swelling. Additional larger studies may determine generalizability to other nonophthalmologist physicians performing POC ocular US.

The Effect of Bedside Ultrasonographic Skin Marking on Infant Lumbar Puncture Success: A Randomized Controlled Trial.

STUDY OBJECTIVE: Lumbar puncture is a commonly performed procedure, although previous studies have documented low rates of successful completion in infants. Ultrasonography can visualize the anatomic landmarks for lumbar puncture and has been shown in some studies to reduce the failure rate of lumbar puncture in adults. We seek to determine whether ultrasonography-assisted site marking increases success for infant lumbar punctures. METHODS: This was a prospective, randomized, controlled trial in an academic pediatric emergency department (ED). We enrolled a convenience sample of infants younger than 6 months between June 2014 and February 2016 and randomized them to either a traditional lumbar puncture arm or an ultrasonography-assisted lumbar puncture arm. Infants in the ultrasonography arm received bedside ultrasonography of the spine by one of 3 study sonographers before lumbar puncture, during which the conus medullaris and most appropriate intervertebral space were identified and marked. The lumbar puncture was then performed by the predetermined ED provider. Our primary outcome was successful first-attempt lumbar puncture. Subjects were considered to have a successful lumbar puncture if cerebrospinal fluid was obtained and RBC counts were less than 1,000/mm3. All outcomes were assessed by intention-to-treat analysis. RESULTS: One hundred twenty-eight patients were enrolled, with 64 in each arm. No differences between the 2 arms were found in the baseline characteristics of the study subjects and providers, except for sex and first-attempt position. The first-attempt success rate was higher for the ultrasonography arm (58%) versus the traditional arm (31%) (absolute risk difference 27% [95% CI 10% to 43%]). Success within 3 attempts was also higher for the ultrasonography arm (75%) versus the traditional arm (44%) (absolute risk difference 31% [95% CI 15% to 47%]). On average, performing bedside ultrasonography on 4 patients (95% CI 2.1 to 6.6) resulted in 1 additional successful lumbar puncture. CONCLUSION: Ultrasonography-assisted site marking improved infant lumbar puncture success in a tertiary care pediatric teaching hospital. This method has the potential to reduce unnecessary hospitalizations and exposures to antibiotics in this vulnerable population.

The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.

Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences.

Failure of Emergency Department Observation Unit Treatment for Skin and Soft Tissue Infections.

BACKGROUND: The effectiveness of observation unit (OU) management of skin and soft tissue infections (SSTI) has not been fully evaluated. OBJECTIVE: This study was performed to determine the rate and risk factors. METHODS: Retrospective cohort study of children ages 2 months to 18 years admitted to the OU for an SSTI between 2007 and 2010 from a pediatric emergency department (ED). Failure of OU therapy was defined as subsequent inpatient ward admission, re-admission after discharge from OU, initial or repeat incision and drainage after OU admission, or change in antibiotic therapy. Demographic, clinical, and lesion characteristics were collected. Comparative analyses were conducted to determine factors associated with OU failure; prolonged OU admission, defined as length of stay ≥ 36 h was evaluated. RESULTS: One hundred ninety-two (63.2%) of 304 subjects with SSTI were eligible; mean age was 6.2 ± 5.3 years, and 52% were male. Fever (≥38°C) in the ED was present for 77 (40%). Most lesions were skin abscesses (53%) and were located on the lower extremity (36%) and buttock/genitourinary (21%). OU treatment failure occurred in 22% (95% confidence interval [CI] 16.5-28.3), primarily due to inpatient admission. Fever on ED presentation was significantly associated with OU failure (odds ratio 2.02; 95% CI 1.02-4.02). Demographics, body site, presence of abscess, and methicillin-resistant Staphylococcus aureus were not associated with OU failure. Prolonged OU admission occurred in 18 subjects (9.4%). CONCLUSION: SSTI can be successfully treated in the OU, though febrile children with SSTI are at risk for OU treatment failure and should be considered for inpatient admission.

Comparison of clinicians to radiologists in assessment of abdominal radiographs for suspected intussusception.

OBJECTIVES: The objectives of this study were to determine agreement of abdominal radiography (AXR) interpretation and to compare test characteristics, between pediatric emergency medicine (PEM) physicians and pediatric radiologists for evaluation of intussusception. METHODS: This was a retrospective cohort study of children aged 3 months to 3 years presenting to a pediatric emergency department (ED) between 2007 and 2009. For inclusion, subjects required an ED presentation for suspected intussusception, performance of a 2-view AXR (supine and upright/lateral decubitus views) and abdominal ultrasound performed during the ED visit, and a subsequent criterion-standard measure for intussusception available (contrast enema, operative report, or clinical follow-up). All AXRs were reviewed by 2 blinded PEM physicians and 2 pediatric radiologists. Interrater agreement (κ) for AXR interpretation and diagnostic test characteristics were calculated for comparison. RESULTS: A total of 286 children were included; intussusception was present in 61 patients (21.3%). Moderate agreement was present between the PEM physicians and radiologists for AXR assessment, with κ = 0.57 (95% confidence interval [CI], 0.47-0.66). Radiologist AXR interpretation had specificity of 86.7% (95% CI, 81.6-90.5), sensitivity of 62.3% (95% CI, 49.8-73.4), positive predictive value of 55.9% (95% CI, 43.3-67.9), and negative predictive value of 89.4% (95% CI, 84.6-93.2). Pediatric emergency medicine physician AXR interpretation had specificity of 68.9% (95% CI, 62.6-74.6), sensitivity of 78.7% (95% CI, 66.9-87.1), positive predictive value of 40.7% (95% CI, 32.2-49.7), and negative predictive value of 92.3% (95% CI, 87.1-95.5). CONCLUSIONS: Agreement between PEM physicians and pediatric radiologists for evaluation of AXR in suspected intussusception is moderate. Sensitivity and negative predictive value of AXR alone are not sufficiently high overall to exclude intussusception; however, PEM physician interpretation of AXR may possess utility in determining need for abdominal ultrasound in low-risk patients given the high negative predictive value.