Practice Variation in the Evaluation and Disposition of Febrile Infants ≤60 Days of Age.

BACKGROUND: Febrile infants commonly present to emergency departments for evaluation. OBJECTIVE: We describe the variation in diagnostic testing and hospitalization of febrile infants ≤60 days of age presenting to the emergency departments in the Pediatric Emergency Care Applied Research Network. METHODS: We enrolled a convenience sample of non-critically ill-appearing febrile infants (temperatures ≥38.0°C/100.4°F) ≤60 days of age who were being evaluated with blood cultures in 26 Pediatric Emergency Care Applied Research Network emergency departments between 2008 and 2013. Patients were divided into younger (0-28 days of age) and older (29-60 days of age) cohorts for analysis. We evaluated diagnostic testing and hospitalization rates by infant age group using chi-square tests and by site using analysis of variance. RESULTS: Four thousand seven hundred seventy-eight patients were eligible for analysis, of whom 1517 (32%) were 0-28 days of age. Rates of lumbar puncture and hospitalization were high (>90%) among infants ≤28 days of age, with chest radiography (35.5%) and viral testing (66.2%) less commonly obtained. Among infants 29-60 days of age, lumbar puncture (69.5%) and hospitalization (64.4%) rates were lower and declined with increasing age, with chest radiography (36.5%) use unchanged and viral testing (52.7%) slightly decreased. There was substantial variation between sites in the older cohort of infants, with lumbar puncture and hospitalization rates ranging from 40% to 90%. CONCLUSIONS: The evaluation and disposition of febrile infants ≤60 days of age is highly variable, particularly among infants who are 29-60 days of age. This variation demonstrates an opportunity to modify diagnostic and management strategies based on current epidemiology to safely decrease invasive testing and hospitalization.

Blood Lead Levels of Children in Flint, Michigan: 2006-2016.

OBJECTIVE: We evaluated the increases in blood lead levels (BLLs) observed in young children in Flint, Michigan, during their exposure to corrosive Flint River water during the years 2014 and 2015 and compared their BLLs to those of Flint children measured during the years 2006-2013 and 2016. STUDY DESIGN: This was a retrospective study design using BLLs extracted from databases from 2006 to 2016. We analyzed a population sample of 15 817 BLLs from children aged ≤5 years with potential exposure to contaminated Flint River water. Percentages of BLLs ≥5.0 µg/dL and geometric mean (GM) BLLs were analyzed over time. RESULTS: A significant decline in the percentages of BLLs ≥5.0 µg/dL from 11.8% in 2006 to 3.2% in 2016 was observed (P < .001). GM ± SE BLLs decreased from 2.33 ± 0.04 µg/dL in 2006 to 1.15 ± 0.02 µg/dL in 2016 (P < .001). GM BLLs increased twice: from 1.75 ± 0.03 µg/dL to 1.87 ± 0.03 µg/dL (2010-2011) and from 1.19 ± 0.02 µg/dL to 1.30 ± 0.02 µg/dL (2014-2015). Overall, from 2006 to 2016, there was a 72.9% decrease in the percentage of children with BLLs ≥5.0 µg/dL and a 50.6% decrease in GM BLLs. CONCLUSION: These findings suggest that the 11 year trend of annual decreases in BLLs in children in Flint, Michigan, reversed to a degree consistent with random variation from 2010 to 2011, and again during the exposure to Flint River water in 2014-2015. Historically, public health efforts to reduce BLLs of young children in Flint have been effective over the 11-year period studied.

Risk of Bacterial Coinfections in Febrile Infants 60 Days Old and Younger with Documented Viral Infections.

OBJECTIVE: To determine the risk of serious bacterial infections (SBIs) in young febrile infants with and without viral infections. STUDY DESIGN: Planned secondary analyses of a prospective observational study of febrile infants 60 days of age or younger evaluated at 1 of 26 emergency departments who did not have clinical sepsis or an identifiable site of bacterial infection. We compared patient demographics, clinical, and laboratory findings, and prevalence of SBIs between virus-positive and virus-negative infants. RESULTS: Of the 4778 enrolled infants, 2945 (61.6%) had viral testing performed, of whom 1200 (48.1%) were virus positive; 44 of the 1200 had SBIs (3.7%; 95% CI, 2.7%-4.9%). Of the 1745 virus-negative infants, 222 had SBIs (12.7%; 95% CI, 11.2%-14.4%). Rates of specific SBIs in the virus-positive group vs the virus-negative group were: UTIs (33 of 1200 [2.8%; 95% CI, 1.9%-3.8%] vs 186 of 1745 [10.7%; 95% CI, 9.2%-12.2%]) and bacteremia (9 of 1199 [0.8%; 95% CI, 0.3%-1.4%] vs 50 of 1743 [2.9%; 95% CI, 2.1%-3.8%]). The rate of bacterial meningitis tended to be lower in the virus-positive group (0.4%) than in the viral-negative group (0.8%); the difference was not statistically significant. Negative viral status (aOR, 3.2; 95% CI, 2.3-4.6), was significantly associated with SBI in multivariable analysis. CONCLUSIONS: Febrile infants ≤60 days of age with viral infections are at significantly lower, but non-negligible risk for SBIs, including bacteremia and bacterial meningitis.

Association of RNA Biosignatures With Bacterial Infections in Febrile Infants Aged 60 Days or Younger.

IMPORTANCE: Young febrile infants are at substantial risk of serious bacterial infections; however, the current culture-based diagnosis has limitations. Analysis of host expression patterns ("RNA biosignatures") in response to infections may provide an alternative diagnostic approach. OBJECTIVE: To assess whether RNA biosignatures can distinguish febrile infants aged 60 days or younger with and without serious bacterial infections. DESIGN, SETTING, AND PARTICIPANTS: Prospective observational study involving a convenience sample of febrile infants 60 days or younger evaluated for fever (temperature >38° C) in 22 emergency departments from December 2008 to December 2010 who underwent laboratory evaluations including blood cultures. A random sample of infants with and without bacterial infections was selected for RNA biosignature analysis. Afebrile healthy infants served as controls. Blood samples were collected for cultures and RNA biosignatures. Bioinformatics tools were applied to define RNA biosignatures to classify febrile infants by infection type. EXPOSURE: RNA biosignatures compared with cultures for discriminating febrile infants with and without bacterial infections and infants with bacteremia from those without bacterial infections. MAIN OUTCOMES AND MEASURES: Bacterial infection confirmed by culture. Performance of RNA biosignatures was compared with routine laboratory screening tests and Yale Observation Scale (YOS) scores. RESULTS: Of 1883 febrile infants (median age, 37 days; 55.7% boys), RNA biosignatures were measured in 279 randomly selected infants (89 with bacterial infections-including 32 with bacteremia and 15 with urinary tract infections-and 190 without bacterial infections), and 19 afebrile healthy infants. Sixty-six classifier genes were identified that distinguished infants with and without bacterial infections in the test set with 87% (95% CI, 73%-95%) sensitivity and 89% (95% CI, 81%-93%) specificity. Ten classifier genes distinguished infants with bacteremia from those without bacterial infections in the test set with 94% (95% CI, 70%-100%) sensitivity and 95% (95% CI, 88%-98%) specificity. The incremental C statistic for the RNA biosignatures over the YOS score was 0.37 (95% CI, 0.30-0.43). CONCLUSIONS AND RELEVANCE: In this preliminary study, RNA biosignatures were defined to distinguish febrile infants aged 60 days or younger with vs without bacterial infections. Further research with larger populations is needed to refine and validate the estimates of test accuracy and to assess the clinical utility of RNA biosignatures in practice.

Sensitivity of plain pelvis radiography in children with blunt torso trauma.

STUDY OBJECTIVE: Plain anteroposterior pelvic radiographs are commonly used to screen children for pelvic fractures or dislocations after blunt torso trauma. The test sensitivity and utility, however, are unclear. We assessed the sensitivity of anteroposterior pelvic radiographs for identifying children with pelvic fractures or dislocations after blunt torso trauma. We hypothesized that anteroposterior pelvic radiographs fail to identify all children with pelvic fractures or dislocations, including patients undergoing operative intervention and those with hypotension. METHODS: We conducted a prospective multicenter observational study of children (<18 years) with blunt torso trauma in the Pediatric Emergency Care Applied Research Network. We compared plain anteroposterior pelvic radiographs to the final diagnosis of pelvic fractures or dislocations as documented by the orthopedic faculty physician before emergency department (ED)/hospital discharge. We described the data with descriptive statistics, including 95% confidence intervals (CIs). RESULTS: Of 12,044 patients enrolled in the parent study, 451 (3.7%; 95% CI 3.4% to 4.1%) had pelvic fractures or dislocations. Of these patients, 65 (14%; 95% CI 11% to 18%) underwent operative intervention and 21 (4.7%; 95% CI 2.9% to 7.0%) had age-adjusted hypotension on initial presentation. In the ED, 382 of the 451 patients underwent plain anteroposterior pelvic radiographs, with a sensitivity of 297 of 382 (78%; 95% CI 73% to 82%) for patients with pelvic fractures or dislocations, 55 of 60 (92%; 95% CI 82% to 97%) for patients undergoing operative intervention, and 14 of 17 (82%; 95% CI 57% to 96%) for patients with hypotension. CONCLUSION: Plain anteroposterior pelvic radiographs have a limited sensitivity for identifying children with pelvic fractures or dislocations after blunt trauma, including patients undergoing operative intervention and those with hypotension.

Characteristics of the pediatric patients treated by the Pediatric Emergency Care Applied Research Network's affiliated EMS agencies.

OBJECTIVE: To describe pediatric patients transported by the Pediatric Emergency Care Applied Research Network's (PECARN's) affiliated emergency medical service (EMS) agencies and the process of submitting and aggregating data from diverse agencies. METHODS: We conducted a retrospective analysis of electronic patient care data from PECARN's partner EMS agencies. Data were collected on all EMS runs for patients less than 19 years old treated between 2004 and 2006. We conducted analyses only for variables with usable data submitted by a majority of participating agencies. The investigators aggregated data between study sites by recoding it into categories and then summarized it using descriptive statistics. RESULTS: Sixteen EMS agencies agreed to participate. Fourteen agencies (88%) across 11 states were able to submit patient data. Two of these agencies were helicopter agencies (HEMS). Mean time to data submission was 378 days (SD 175). For the 12 ground EMS agencies that submitted data, there were 514,880 transports, with a mean patient age of 9.6 years (SD 6.4); 53% were male, and 48% were treated by advanced life support (ALS) providers. Twenty-two variables were aggregated and analyzed, but not all agencies were able to submit all analyzed variables and for most variables there were missing data. Based on the available data, median response time was 6 minutes (IQR: 4-9), scene time 15 minutes (IQR: 11-21), and transport time 9 minutes (IQR: 6-13). The most common chief complaints were traumatic injury (28%), general illness (10%), and respiratory distress (9%). Vascular access was obtained for 14% of patients, 3% received asthma medication, <1% pain medication, <1% assisted ventilation, <1% seizure medication, <1% an advanced airway, and <1% CPR. Respiratory rate, pulse, systolic blood pressure, and GCS were categorized by age and the majority of children were in the normal range except for systolic blood pressure in those under one year old. CONCLUSIONS: Despite advances in data definitions and increased use of electronic databases nationally, data aggregation across EMS agencies was challenging, in part due to variable data collection methods and missing data. In our sample, only a small proportion of pediatric EMS patients required prehospital medications or interventions.

Identifying children at very low risk of clinically important blunt abdominal injuries.

STUDY OBJECTIVE: We derive a prediction rule to identify children at very low risk for intra-abdominal injuries undergoing acute intervention and for whom computed tomography (CT) could be obviated. METHODS: We prospectively enrolled children with blunt torso trauma in 20 emergency departments. We used binary recursive partitioning to create a prediction rule to identify children at very low risk of intra-abdominal injuries undergoing acute intervention (therapeutic laparotomy, angiographic embolization, blood transfusion for abdominal hemorrhage, or intravenous fluid for ≥2 nights for pancreatic/gastrointestinal injuries). We considered only historical and physical examination variables with acceptable interrater reliability. RESULTS: We enrolled 12,044 children with a median age of 11.1 years (interquartile range 5.8, 15.1 years). Of the 761 (6.3%) children with intra-abdominal injuries, 203 (26.7%) received acute interventions. The prediction rule consisted of (in descending order of importance) no evidence of abdominal wall trauma or seat belt sign, Glasgow Coma Scale score greater than 13, no abdominal tenderness, no evidence of thoracic wall trauma, no complaints of abdominal pain, no decreased breath sounds, and no vomiting. The rule had a negative predictive value of 5,028 of 5,034 (99.9%; 95% confidence interval [CI] 99.7% to 100%), sensitivity of 197 of 203 (97%; 95% CI 94% to 99%), specificity of 5,028 of 11,841 (42.5%; 95% CI 41.6% to 43.4%), and negative likelihood ratio of 0.07 (95% CI 0.03 to 0.15). CONCLUSION: A prediction rule consisting of 7 patient history and physical examination findings, and without laboratory or ultrasonographic information, identifies children with blunt torso trauma who are at very low risk for intra-abdominal injury undergoing acute intervention. These findings require external validation before implementation.

Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure.

BACKGROUND: Mobile health (mHealth) strategies initiated in safety-net Emergency Departments may be one approach to address the US hypertension epidemic, but the optimal mHealth components or dose are unknown. METHODS: Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, Michigan. Reach Out consisted of 3 mHealth components, each with 2 doses: (1) healthy behavior text messaging (yes versus no), (2) prompted self-measured blood pressure (BP) monitoring and feedback (weekly versus daily), and (3) facilitated primary care provider appointment scheduling and transportation (yes versus no). The primary outcome was a change in systolic BP from baseline to 12 months. In a complete case analysis, we fit a linear regression model and accounted for age, sex, race, and prior BP medications to explore the association between systolic BP and each mHealth component. RESULTS: Among 488 randomized participants, 211 (43%) completed follow-up. Mean age was 45.5 years, 61% were women, 54% were Black people, 22% did not have a primary care doctor, 21% lacked transportation, and 51% were not taking antihypertensive medications. Overall, systolic BP declined after 6 months (-9.2 mm Hg [95% CI, -12.2 to -6.3]) and 12 months (-6.6 mm Hg, -9.3 to -3.8), without a difference across the 8 treatment arms. The higher dose of mHealth components were not associated with a greater change in systolic BP; healthy behavior text messages (point estimate, mmHG=-0.5 [95% CI, -6.0 to 5]; P=0.86), daily self-measured BP monitoring (point estimate, mmHG=1.9 [95% CI, -3.7 to 7.5]; P=0.50), and facilitated primary care provider scheduling and transportation (point estimate, mmHG=0 [95% CI, -5.5 to 5.6]; P=0.99). CONCLUSIONS: Among participants with elevated BP recruited from an urban safety-net Emergency Department, BP declined over the 12-month intervention period. There was no difference in change in systolic BP among the 3 mHealth components. Reach Out demonstrated the feasibility of reaching medically underserved people with high BP cared for at a safety-net Emergency Departments, yet the efficacy of the Reach Out mHealth intervention components requires further study. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03422718.

Serious Bacterial Infections in Young Febrile Infants With Positive Urinalysis Results.

It is unknown whether febrile infants 29 to 60 days old with positive urinalysis results require routine lumbar punctures for evaluation of bacterial meningitis. OBJECTIVE: To determine the prevalence of bacteremia and/or bacterial meningitis in febrile infants ≤60 days of age with positive urinalysis (UA) results. METHODS: Secondary analysis of a prospective observational study of noncritical febrile infants ≤60 days between 2011 and 2019 conducted in the Pediatric Emergency Care Applied Research Network emergency departments. Participants had temperatures ≥38°C and were evaluated with blood cultures and had UAs available for analysis. We report the prevalence of bacteremia and bacterial meningitis in those with and without positive UA results. RESULTS: Among 7180 infants, 1090 (15.2%) had positive UA results. The risk of bacteremia was higher in those with positive versus negative UA results (63/1090 [5.8%] vs 69/6090 [1.1%], difference 4.7% [3.3% to 6.1%]). There was no difference in the prevalence of bacterial meningitis in infants ≤28 days of age with positive versus negative UA results (∼1% in both groups). However, among 697 infants aged 29 to 60 days with positive UA results, there were no cases of bacterial meningitis in comparison to 9 of 4153 with negative UA results (0.2%, difference -0.2% [-0.4% to -0.1%]). In addition, there were no cases of bacteremia and/or bacterial meningitis in the 148 infants ≤60 days of age with positive UA results who had the Pediatric Emergency Care Applied Research Network low-risk blood thresholds of absolute neutrophil count <4 × 103 cells/mm3 and procalcitonin <0.5 ng/mL. CONCLUSIONS: Among noncritical febrile infants ≤60 days of age with positive UA results, there were no cases of bacterial meningitis in those aged 29 to 60 days and no cases of bacteremia and/or bacterial meningitis in any low-risk infants based on low-risk blood thresholds in both months of life. These findings can guide lumbar puncture use and other clinical decision making.

Intracranial hemorrhage after blunt head trauma in children with bleeding disorders.

OBJECTIVE: To determine computerized tomography (CT) use and prevalence of traumatic intracranial hemorrhage (ICH) in children with and without congenital and acquired bleeding disorders. STUDY DESIGN: We compared CT use and ICH prevalence in children with and without bleeding disorders in a multicenter cohort study of 43 904 children <18 years old with blunt head trauma evaluated in 25 emergency departments. RESULTS: A total of 230 children had bleeding disorders; all had Glasgow Coma Scale (GCS) scores of 14 to 15. These children had higher CT rates than children without bleeding disorders and GCS scores of 14 to 15 (risk ratio, 2.29; 95% CI, 2.15 to 2.44). Of the children who underwent imaging with CT, 2 of 186 children with bleeding disorders had ICH (1.1%; 95% CI, 0.1 to 3.8) , compared with 655 of 14 969 children without bleeding disorders (4.4%; 95% CI, 4.1-4.7; rate ratio, 0.25; 95% CI, 0.06 to 0.98). Both children with bleeding disorders and ICHs had symptoms; none of the children required neurosurgery. CONCLUSION: In children with head trauma, CTs are obtained twice as often in children with bleeding disorders, although ICHs occurred in only 1.1%, and these patients had symptoms. Routine CT imaging after head trauma may not be required in children without symptoms who have congenital and acquired bleeding disorders.

Do children with blunt head trauma and normal cranial computed tomography scan results require hospitalization for neurologic observation?

STUDY OBJECTIVE: Children evaluated in the emergency department (ED) with minor blunt head trauma, defined by initial Glasgow Coma Scale (GCS) scores of 14 or 15, are frequently hospitalized despite normal cranial computed tomography (CT) scan results. We seek to identify the frequency of neurologic complications in children with minor blunt head trauma and normal ED CT scan results. METHODS: We conducted a prospective, multicenter observational cohort study of children younger than 18 years with blunt head trauma (including isolated head or multisystem trauma) at 25 centers between 2004 and 2006. In this substudy, we analyzed individuals with initial GCS scores of 14 or 15 who had normal cranial CT scan results during ED evaluation. An abnormal imaging study result was defined by any intracranial hemorrhage, cerebral edema, pneumocephalus, or any skull fracture. Patients with normal CT scan results who were hospitalized were followed to determine neurologic outcomes; those discharged to home from the ED received telephone/mail follow-up to assess for subsequent neuroimaging, neurologic complications, or neurosurgical intervention. RESULTS: Children (13,543) with GCS scores of 14 or 15 and normal ED CT scan results were enrolled, including 12,584 (93%) with GCS scores of 15 and 959 (7%) with GCS scores of 14. Of 13,543 patients, 2,485 (18%) were hospitalized, including 2,107 of 12,584 (17%) with GCS scores of 15 and 378 of 959 (39%) with GCS scores of 14. Of the 11,058 patients discharged home from the ED, successful telephone/mail follow-up was completed for 8,756 (79%), and medical record, continuous quality improvement, and morgue review was performed for the remaining patients. One hundred ninety-seven (2%) children received subsequent CT or magnetic resonance imaging (MRI); 5 (0.05%) had abnormal CT/MRI scan results and none (0%; 95% confidence interval [CI] 0% to 0.03%) received a neurosurgical intervention. Of the 2,485 hospitalized patients, 137 (6%) received subsequent CT or MRI; 16 (0.6%) had abnormal CT/MRI scan results and none (0%; 95% CI 0% to 0.2%) received a neurosurgical intervention. The negative predictive value for neurosurgical intervention for a child with an initial GCS score of 14 or 15 and a normal CT scan result was 100% (95% CI 99.97% to 100%). CONCLUSION: Children with blunt head trauma and initial ED GCS scores of 14 or 15 and normal cranial CT scan results are at very low risk for subsequent traumatic findings on neuroimaging and extremely low risk of needing neurosurgical intervention. Hospitalization of children with minor head trauma after normal CT scan results for neurologic observation is generally unnecessary.

Factors associated with cervical spine injury in children after blunt trauma.

STUDY OBJECTIVE: Cervical spine injuries in children are rare. However, immobilization and imaging for potential cervical spine injury after trauma are common and are associated with adverse effects. Risk factors for cervical spine injury have been developed to safely limit immobilization and radiography in adults, but not in children. The purpose of our study is to identify risk factors associated with cervical spine injury in children after blunt trauma. METHODS: We conducted a case-control study of children younger than 16 years, presenting after blunt trauma, and who received cervical spine radiographs at 17 hospitals in the Pediatric Emergency Care Applied Research Network (PECARN) between January 2000 and December 2004. Cases were children with cervical spine injury. We created 3 control groups of children free of cervical spine injury: (1) random controls, (2) age and mechanism of injury-matched controls, and (3) for cases receiving out-of-hospital emergency medical services (EMS), age-matched controls who also received EMS care. We abstracted data from 3 sources: PECARN hospital, referring hospital, and out-of-hospital patient records. We performed multiple logistic regression analyses to identify predictors of cervical spine injury and calculated the model's sensitivity and specificity. RESULTS: We reviewed 540 records of children with cervical spine injury and 1,060, 1,012, and 702 random, mechanism of injury, and EMS controls, respectively. In the analysis using random controls, we identified 8 factors associated with cervical spine injury: altered mental status, focal neurologic findings, neck pain, torticollis, substantial torso injury, conditions predisposing to cervical spine injury, diving, and high-risk motor vehicle crash. Having 1 or more factors was 98% (95% confidence interval 96% to 99%) sensitive and 26% (95% confidence interval 23% to 29%) specific for cervical spine injury. We identified similar risk factors in the other analyses. CONCLUSION: We identified an 8-variable model for cervical spine injury in children after blunt trauma that warrants prospective refinement and validation.

Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study.

BACKGROUND: CT imaging of head-injured children has risks of radiation-induced malignancy. Our aim was to identify children at very low risk of clinically-important traumatic brain injuries (ciTBI) for whom CT might be unnecessary. METHODS: We enrolled patients younger than 18 years presenting within 24 h of head trauma with Glasgow Coma Scale scores of 14-15 in 25 North American emergency departments. We derived and validated age-specific prediction rules for ciTBI (death from traumatic brain injury, neurosurgery, intubation >24 h, or hospital admission >or=2 nights). FINDINGS: We enrolled and analysed 42 412 children (derivation and validation populations: 8502 and 2216 younger than 2 years, and 25 283 and 6411 aged 2 years and older). We obtained CT scans on 14 969 (35.3%); ciTBIs occurred in 376 (0.9%), and 60 (0.1%) underwent neurosurgery. In the validation population, the prediction rule for children younger than 2 years (normal mental status, no scalp haematoma except frontal, no loss of consciousness or loss of consciousness for less than 5 s, non-severe injury mechanism, no palpable skull fracture, and acting normally according to the parents) had a negative predictive value for ciTBI of 1176/1176 (100.0%, 95% CI 99.7-100 0) and sensitivity of 25/25 (100%, 86.3-100.0). 167 (24.1%) of 694 CT-imaged patients younger than 2 years were in this low-risk group. The prediction rule for children aged 2 years and older (normal mental status, no loss of consciousness, no vomiting, non-severe injury mechanism, no signs of basilar skull fracture, and no severe headache) had a negative predictive value of 3798/3800 (99.95%, 99.81-99.99) and sensitivity of 61/63 (96.8%, 89.0-99.6). 446 (20.1%) of 2223 CT-imaged patients aged 2 years and older were in this low-risk group. Neither rule missed neurosurgery in validation populations. INTERPRETATION: These validated prediction rules identified children at very low risk of ciTBIs for whom CT can routinely be obviated. FUNDING: The Emergency Medical Services for Children Programme of the Maternal and Child Health Bureau, and the Maternal and Child Health Bureau Research Programme, Health Resources and Services Administration, US Department of Health and Human Services.

A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

BACKGROUND: Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. METHODS: We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. RESULTS: Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. CONCLUSIONS: In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].).

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.

BACKGROUND: Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS: Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION: The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.

Provider-Level and Hospital-Level Factors and Process Measures of Quality Care Delivered in Pediatric Emergency Departments.

OBJECTIVE: Differences in the quality of emergency department (ED) care are often attributed to nonclinical factors such as variations in the structure, systems, and processes of care. Few studies have examined these associations among children. We aimed to determine whether process measures of quality of care delivered to patients receiving care in children's hospital EDs were associated with physician-level or hospital-level factors. METHODS: We included children (<18 years old) who presented to any of the 12 EDs participating in the Pediatric Emergency Care Applied Research Network (PECARN) between January 2011 and December 2011. We measured quality of care from medical record reviews using a previously validated implicit review instrument with a summary score ranging from 5 to 35, and examined associations between process measures of quality and physician- and hospital-level factors using a mixed-effects linear regression model adjusted for patient case-mix, with hospital site as a random effect. RESULTS: Among the 620 ED encounters reviewed, we did not find process measures of quality to be associated with any physician-level factors such as physician sex, years since medical school graduation, or physician training. We found, however, that process measures of quality were positively associated with delivery at freestanding children's hospitals (1.96 points higher in quality compared to nonfreestanding status, 95% confidence interval: 0.49, 3.43) and negatively associated with higher annual ED patient volume (-0.03 points per thousand patients, 95% confidence interval: -0.05, -0.01). CONCLUSION: Process measures of quality of care delivered to children were higher among patients treated at freestanding children's hospitals but lower among patients treated at higher volume EDs.

Blood Lead Levels in Females of Childbearing Age in Flint, Michigan, and the Water Crisis.

OBJECTIVE: To compare blood lead levels in females of childbearing age, 12-50 years, living within and adjacent to Flint, Michigan, before, during, and after the Flint River water exposure and compare the levels to those that have been shown to cause fetal loss and preterm birth. METHODS: The switch in the community water source to the Flint River occurred on April 25, 2014, and was reverted to the original source on October 15, 2015. Using a retrospective cross-sectional study design using geocoded blood lead levels obtained from all females of childbearing age available from a single hospital database, we compared blood lead levels for the following 18-month time periods: April 25, 2012-October 15, 2013 (PRE), April 25, 2014-October 15, 2015 (DURING), and April 25, 2016-October 15, 2017 (POST). RESULTS: Results are reported as geometric mean (95% CI). Within Flint, PRE blood lead levels in females of childbearing age were 0.69 micrograms/dL (95% CI 0.63-0.75), DURING blood lead levels were 0.65 micrograms/dL (95% CI 0.60-0.71), and POST blood lead levels were 0.55 micrograms/dL (95% CI 0.54-0.56). DURING Flint River water exposure blood lead levels were not significantly different than the PRE Flint River water time period. POST Flint River water exposure blood lead levels were significantly lower than both PRE and DURING levels. Overall, lower blood lead levels were found outside the Flint boundary in all cohorts. CONCLUSION: Blood lead levels in Flint females of childbearing age did not increase during the Flint River water exposure and subsequent 18-month time period. Mean blood lead levels during the Flint River water exposure are not consistent with the markedly higher blood lead levels reported in the literature to be associated with fetal loss, low birth weight, or preterm birth.

Analysis of blood lead levels of young children in Flint, Michigan before and during the 18-month switch to Flint River water.

Background: The toxicity of lead, like any xenobiotic, is directly linked to the duration of exposure and toxin concentration in the body. The elevation in blood lead levels (BLLs) in young Flint, Michigan children noted in time-periods before, and during the 18-month exposure to Flint River water (FRW) from 25 April 2014 to 15 October 2015 is well-known internationally. The length of time BLLs were elevated is unknown, yet key in understanding the potential health impact of the event. The objective of this study was to evaluate whether BLLs in Flint children were increased during the entire 18-month FRW exposure compared to similar earlier time periods. Methods: We conducted a retrospective study analyzing BLLs from Flint children aged 5 years and under. The geometric mean (GM) BLLs and percentages of BLLs ≥5.0 µg/dL in Period I: 25 April 2006 to 15 October 2007 (earliest timeframe available for study) and Period II: 25 April 2012 to 15 October 2013 (timeframe immediately before the water switch), were compared to Period III, 25 April 2014 to 15 October 2015 (FRW exposure). Results: There were 5663 BLLs available for study. GM ± SE BLLs decreased from 2.19 ± 0.03 µg/dL in Period I to 1.47 ± 0.02 µg/dL in Period II [95% CI, 0.64, 0.79]; p<.001 and decreased further to 1.32 ± 0.02 µg/dL during the FRW Period III [95% CI, 0.79, 0.95]; p<.001. The percentage of BLLs ≥5.0 µg/dL decreased from Period I (10.6%) to Period II (3.3%) [95% CI, 5.7, 8.8]; p<.001 and from Period I to Period III (3.9%) [95% CI, 5.0, 8.2]; p=.002. The 0.6% increase from Period II to Period III was not statistically significant [95% CI, -1.9, 0.57]; p=.30. Conclusion: Analyses of GM and percentages ≥5.0 µg/dL of BLLs do not support the occurrence of a global increase in BLLs in young children of Flint during the entire 18-month period of FRW exposure.

A Clinical Prediction Rule to Identify Febrile Infants 60 Days and Younger at Low Risk for Serious Bacterial Infections.

Importance: In young febrile infants, serious bacterial infections (SBIs), including urinary tract infections, bacteremia, and meningitis, may lead to dangerous complications. However, lumbar punctures and hospitalizations involve risks and costs. Clinical prediction rules using biomarkers beyond the white blood cell count (WBC) may accurately identify febrile infants at low risk for SBIs. Objective: To derive and validate a prediction rule to identify febrile infants 60 days and younger at low risk for SBIs. Design, Setting, and Participants: Prospective, observational study between March 2011 and May 2013 at 26 emergency departments. Convenience sample of previously healthy febrile infants 60 days and younger who were evaluated for SBIs. Data were analyzed between April 2014 and April 2018. Exposures: Clinical and laboratory data (blood and urine) including patient demographics, fever height and duration, clinical appearance, WBC, absolute neutrophil count (ANC), serum procalcitonin, and urinalysis. We derived and validated a prediction rule based on these variables using binary recursive partitioning analysis. Main Outcomes and Measures: Serious bacterial infection, defined as urinary tract infection, bacteremia, or bacterial meningitis. Results: We derived the prediction rule on a random sample of 908 infants and validated it on 913 infants (mean age was 36 days, 765 were girls [42%], 781 were white and non-Hispanic [43%], 366 were black [20%], and 535 were Hispanic [29%]). Serious bacterial infections were present in 170 of 1821 infants (9.3%), including 26 (1.4%) with bacteremia, 151 (8.3%) with urinary tract infections, and 10 (0.5%) with bacterial meningitis; 16 (0.9%) had concurrent SBIs. The prediction rule identified infants at low risk of SBI using a negative urinalysis result, an ANC of 4090/µL or less (to convert to ×109 per liter, multiply by 0.001), and serum procalcitonin of 1.71 ng/mL or less. In the validation cohort, the rule sensitivity was 97.7% (95% CI, 91.3-99.6), specificity was 60.0% (95% CI, 56.6-63.3), negative predictive value was 99.6% (95% CI, 98.4-99.9), and negative likelihood ratio was 0.04 (95% CI, 0.01-0.15). One infant with bacteremia and 2 infants with urinary tract infections were misclassified. No patients with bacterial meningitis were missed by the rule. The rule performance was nearly identical when the outcome was restricted to bacteremia and/or bacterial meningitis, missing the same infant with bacteremia. Conclusions and Relevance: We derived and validated an accurate prediction rule to identify febrile infants 60 days and younger at low risk for SBIs using the urinalysis, ANC, and procalcitonin levels. Once further validated on an independent cohort, clinical application of the rule has the potential to decrease unnecessary lumbar punctures, antibiotic administration, and hospitalizations.

Accuracy of the Urinalysis for Urinary Tract Infections in Febrile Infants 60 Days and Younger.

OBJECTIVES: Reports of the test accuracy of the urinalysis for diagnosing urinary tract infections (UTIs) in young febrile infants have been variable. We evaluated the test characteristics of the urinalysis for diagnosing UTIs, with and without associated bacteremia, in young febrile infants. METHODS: We performed a planned secondary analysis of data from a prospective study of febrile infants ≤60 days old at 26 emergency departments in the Pediatric Emergency Care Applied Research Network. We evaluated the test characteristics of the urinalysis for diagnosing UTIs, with and without associated bacteremia, by using 2 definitions of UTI: growth of ≥50 000 or ≥10 000 colony-forming units (CFUs) per mL of a uropathogen. We defined a positive urinalysis by the presence of any leukocyte esterase, nitrite, or pyuria (>5 white blood cells per high-power field). RESULTS: Of 4147 infants analyzed, 289 (7.0%) had UTIs with colony counts ≥50 000 CFUs/mL, including 27 (9.3%) with bacteremia. For these UTIs, a positive urinalysis exhibited sensitivities of 0.94 (95% confidence interval [CI]: 0.91-0.97), regardless of bacteremia; 1.00 (95% CI: 0.87-1.00) with bacteremia; and 0.94 (95% CI: 0.90-0.96) without bacteremia. Specificity was 0.91 (95% CI: 0.90-0.91) in all groups. For UTIs with colony counts ≥10 000 CFUs/mL, the sensitivity of the urinalysis was 0.87 (95% CI: 0.83-0.90), and specificity was 0.91 (95% CI: 0.90-0.92). CONCLUSIONS: The urinalysis is highly sensitive and specific for diagnosing UTIs, especially with ≥50 000 CFUs/mL, in febrile infants ≤60 days old, and particularly for UTIs with associated bacteremia.