Referrals for Pediatric Appendicitis to a Tertiary Care Children's Hospital.

OBJECTIVES: This study aimed to analyze pediatric referrals for definite or possible appendicitis, to compare clinical predictors and laboratory values between patients with and without a final diagnosis of appendicitis, and to determine the accuracy of prereferral diagnostic interpretations of computed tomography scans, ultrasound, and magnetic resonance imaging modalities. METHODS: We conducted a retrospective analysis of pediatric patients referred from 2015 to 2019 to a tertiary care children's emergency department with definitive or possible appendicitis. Data abstracted included patient demographics, clinical symptoms, physical examination findings, laboratory results, and diagnostic imaging findings (by the referring center and the pediatric radiologist at the accepting center). An Alvarado and Appendicitis Inflammatory Response (AIR) score was calculated for each patient. RESULTS: Analysis was performed on 381 patients; 226 (59%) had a final diagnosis of appendicitis. Patients with appendicitis were more likely to have symptoms of nausea ( P < 0.0001) and vomiting ( P < 0.0001), have a higher mean temperature ( P = 0.025), right lower quadrant abdominal pain to palpation ( P = <0.0001), rebound tenderness ( P < 0.0001), a higher mean Alvarado score [5.35 vs 3.45 ( P < 0.0001)], and a higher mean AIR score [4.02 vs 2.17 ( P < 0.0001)]. Of the 97 diagnostic images initially interpreted as appendicitis by the referring center, 10 (10.3%) were read as no evidence of appendicitis. Of the 62 diagnostic images initially interpreted as "possible appendicitis" by the referring center, 34 (54.8%) were read as no evidence of appendicitis. Of those diagnostic images initially interpreted as "appendicitis" or "possible appendicitis" by the referring center, 24/89 (27.0%) of computed tomography scans, 17/62 (27.4%) of ultrasounds, and 3/8 (37.5%) of magnetic resonance imaging results were read as no evidence of appendicitis. CONCLUSIONS: Usage of established scoring algorithms, such as Alvarado and AIR, may decrease the unnecessary cost of diagnostic imaging and transfer to tertiary care. Virtual radiology consultations may be 1 potential solution to improve the referral process for pediatric appendicitis if initial interpretation is uncertain.

Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.

BACKGROUND: Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS: In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS: Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS: Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

Individualized therapy for persistent asthma in young children.

BACKGROUND: Phenotypic presentations in young children with asthma are varied and might contribute to differential responses to asthma controller medications. METHODS: The Individualized Therapy for Asthma in Toddlers study was a multicenter, randomized, double-blind, double-dummy clinical trial in children aged 12 to 59 months (n = 300) with asthma necessitating treatment with daily controller (Step 2) therapy. Participants completed a 2- to 8-week run-in period followed by 3 crossover periods with daily inhaled corticosteroids (ICSs), daily leukotriene receptor antagonists, and as-needed ICS treatment coadministered with albuterol. The primary outcome was differential response to asthma medication based on a composite measure of asthma control. The primary analysis involved 2 stages: determination of differential response and assessment of whether 3 prespecified features (aeroallergen sensitization, previous exacerbations, and sex) predicted a differential response. RESULTS: Seventy-four percent (170/230) of children with analyzable data had a differential response to the 3 treatment strategies. Within differential responders, the probability of best response was highest for a daily ICS and was predicted by aeroallergen sensitization but not exacerbation history or sex. The probability of best response to daily ICS was further increased in children with both aeroallergen sensitization and blood eosinophil counts of 300/µL or greater. In these children daily ICS use was associated with more asthma control days and fewer exacerbations compared with the other treatments. CONCLUSIONS: In young children with asthma necessitating Step 2 treatment, phenotyping with aeroallergen sensitization and blood eosinophil counts is useful for guiding treatment selection and identifies children with a high exacerbation probability for whom treatment with a daily ICS is beneficial despite possible risks of growth suppression.

Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids.

BACKGROUND: For children who have uncontrolled asthma despite the use of low-dose inhaled corticosteroids (ICS), evidence to guide step-up therapy is lacking. METHODS: We randomly assigned 182 children (6 to 17 years of age), who had uncontrolled asthma while receiving 100 microg of fluticasone twice daily, to receive each of three blinded step-up therapies in random order for 16 weeks: 250 microg of fluticasone twice daily (ICS step-up), 100 microg of fluticasone plus 50 microg of a long-acting beta-agonist twice daily (LABA step-up), or 100 microg of fluticasone twice daily plus 5 or 10 mg of a leukotriene-receptor antagonist daily (LTRA step-up). We used a triple-crossover design and a composite of three outcomes (exacerbations, asthma-control days, and the forced expiratory volume in 1 second) to determine whether the frequency of a differential response to the step-up regimens was more than 25%. RESULTS: A differential response occurred in 161 of 165 patients who were evaluated (P<0.001). The response to LABA step-up therapy was most likely to be the best response, as compared with responses to LTRA step-up (relative probability, 1.6; 95% confidence interval [CI], 1.1 to 2.3; P=0.004) and ICS step-up (relative probability, 1.7; 95% CI, 1.2 to 2.4; P=0.002). Higher scores on the Asthma Control Test before randomization (indicating better control at baseline) predicted a better response to LABA step-up (P=0.009). White race predicted a better response to LABA step-up, whereas black patients were least likely to have a best response to LTRA step-up (P=0.005). CONCLUSIONS: Nearly all the children had a differential response to each step-up therapy. LABA step-up was significantly more likely to provide the best response than either ICS or LTRA step-up. However, many children had a best response to ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy. (ClinicalTrials.gov number, NCT00395304.)

Zone I Revision Finger Amputations Performed in the Emergency Department Compared With Those Performed in the Operating Room.

Finger amputations are commonly encountered. These may be revised in the emergency department (ED) or the operating room (OR). Previous studies have demonstrated the cost-effectiveness associated with procedures performed in the ED. Patient outcomes have not been described. We retrospectively reviewed patients who presented to our level 1 trauma center with a traumatic partial or complete finger amputation through flexor tendon zone I. All were treated with revision amputation performed in either the ED or the OR between January 2012 and December 2017. A total of 172 patient charts were included. Ninety-three of the revision amputations were performed in the ED, while 79 were performed in the OR. There was no difference in age, race, sex, having a manual labor job, medical comorbidities, or mechanism of injury between the groups. Compared with procedures performed in the ED, procedures performed in the OR had a higher rate of delayed healing, a longer stay in the hospital, and a higher referral to therapy postoperatively. Length of follow-up and number of follow-up visits were not statistically different based on location of procedure. There was no difference in post-procedural infection rate or need for revision procedure between the groups. Our data support the efficacy of performing revision amputation procedures in the ED. Recorded patient complications and subsequent treatment after revision amputations performed in the ED vs the OR were comparable. Those performed in the ED potentially decrease the burden placed on the patient and the health care system. [Orthopedics. 202x;4x(x):xx-xx.].

Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Daily inhaled corticosteroids are an effective treatment for mild persistent asthma, but some children have exacerbations even with good day-to-day control, and many discontinue treatment after becoming asymptomatic. We assessed the effectiveness of an inhaled corticosteroid (beclomethasone dipropionate) used as rescue treatment. METHODS: In this 44-week, randomised, double-blind, placebo-controlled trial we enrolled children and adolescents with mild persistent asthma aged 5-18 years from five clinical centres in the USA. A computer-generated randomisation sequence, stratified by clinical centre and age group, was used to randomly assign participants to one of four treatment groups: twice daily beclomethasone with beclomethasone plus albuterol as rescue (combined group); twice daily beclomethasone with placebo plus albuterol as rescue (daily beclomethasone group); twice daily placebo with beclomethasone plus albuterol as rescue (rescue beclomethasone group); and twice daily placebo with placebo plus albuterol as rescue (placebo group). Twice daily beclomethasone treatment was one puff of beclomethasone (40 µg per puff) or placebo given in the morning and evening. Rescue beclomethasone treatment was two puffs of beclomethasone or placebo for each two puffs of albuterol (180 µg) needed for symptom relief. The primary outcome was time to first exacerbation that required oral corticosteroids. A secondary outcome measured linear growth. Analysis was by intention to treat. This study is registered with clinicaltrials.gov, number NCT00394329. RESULTS: 843 children and adolescents were enrolled into this trial, of whom 288 were assigned to one of four treatment groups; combined (n=71), daily beclomethasone (n=72), rescue beclomethasone (n=71), and placebo (n=74)-555 individuals were excluded during the run-in, according to predefined criteria. Compared with the placebo group (49%, 95% CI 37-61), the frequency of exacerbations was lower in the daily (28%, 18-40, p=0·03), combined (31%, 21-43, p=0·07), and rescue (35%, 24-47, p=0·07) groups. Frequency of treatment failure was 23% (95% CI 14-43) in the placebo group, compared with 5·6% (1·6-14) in the combined (p=0·012), 2·8% (0-10) in the daily (p=0·009), and 8·5% (2-15) in the rescue (p=0·024) groups. Compared with the placebo group, linear growth was 1·1 cm (SD 0·3) less in the combined and daily arms (p<0·0001), but not the rescue group (p=0·26). Only two individuals had severe adverse events; one in the daily beclomethasone group had viral meningitis and one in the combined group had bronchitis. INTERPRETATION: Children with mild persistent asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, mild asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled corticosteroid treatment and related side-effects such as growth impairment can therefore be avoided. FUNDING: National Heart, Lung and Blood Institute.

Sex and race visual representation in emergency medicine textbooks and the hidden curriculum.

Introduction: In addition to formal training, informal training often occurs through a hidden curriculum. As the hidden curriculum shapes the knowledge and values held by learners, we must consider its role in implicit bias. One example is through the selection of images used in formal instruction. This study aimed to examine the representation of sex and race among images in two textbooks in emergency medicine (EM). Methods: We performed a cross-sectional study of the sex and race representation of figures in Rosen's Emergency Medicine: Concepts and Clinical Practice 9th Edition and Tintinalli's Emergency Medicine: A Comprehensive Study Guide 9th Edition. Two reviewers screened all images for inclusion, with disagreements resolved by a third reviewer. Images were excluded if they did not include visualized skin. Two reviewers independently reviewed each image and assessed the sex, race, and roles in the image. A third reviewer resolved any disagreements. Results: A total of 959 images (Rosen's n = 377; Tintinalli's n = 582) met inclusion criteria. Race was estimated in 877 cases (91.3%). Of those, White individuals comprised 77.6% (95% confidence interval [CI] 75.0%-80.2%). Sex was estimated in 362 cases (37.7%). Of those images, males comprised 70.2% (95% CI 65.4%-74.9%), and females comprised 29.8% (95% CI 25.1%-34.6%). Conclusion: There is a male sex and White race predominance in visual representation among two EM textbooks. We propose a call to action for the mindful selection of images in formal education to represent diversity, equity, and inclusion and close the gap between the formal and hidden curriculum.

Librarian instruction-delivery modality preferences for professional continuing education.

OBJECTIVES: Attending professional continuing education (CE) is an important component of librarianship. This research study identified librarians' preferences in delivery modalities of instruction for professional CE. The study also identified influential factors associated with attending CE classes. METHODS: Five instruction-delivery modalities and six influential factors were identified for inclusion in an online survey. The survey completed by members of the American Library Association (ALA), Special Libraries Association (SLA), and Medical Library Association (MLA) provided the data for analysis of librarian preferences and influential factors. RESULTS: The majority of respondents were MLA members, followed by ALA and SLA members. Librarians from all three library associations preferred the face-to-face instructional modality. The most influential factor associated with the decision to attend a professional CE class was cost. CONCLUSIONS: All five instruction-delivery modalities present useful structures for imparting professional CE. As librarians' experience with different modalities increases and as technology improves, preferences in instruction delivery may shift. But at present, face-to-face remains the most preferred modality. Based on the results of this study, cost was the most influential factor associated with attending a CE class. This may change as additional influential factors are identified and analyzed in future studies.

Phenotypic predictors of long-term response to inhaled corticosteroid and leukotriene modifier therapies in pediatric asthma.

BACKGROUND: In children with mild-to-moderate persistent asthma, identification of phenotypic predictors to guide selection of a controller regimen is essential. OBJECTIVE: We sought to identify phenotypic characteristics having predictive value for the difference in treatment responses between twice-daily fluticasone and once-daily montelukast. METHODS: Data from the Pediatric Asthma Controller Trial were assessed with multivariate analysis. Outcomes included the change in asthma control days (ACDs), FEV(1), peak expiratory flow, and time to first asthma exacerbation measured over a 1-year treatment period. RESULTS: The mean age was 9.6 +/- 2.1 years, 60% were male, 50% had a parental history of asthma, and 78% had positive aeroallergen skin prick test responses. The mean percent predicted prebronchodilator FEV(1) was 97.8% +/- 12.9%, the median PC(20) value was 0.93 mg/mL, and the median exhaled nitric oxide (eNO) level was 25.2 ppb. A history of parental asthma best predicted the expected treatment benefit with fluticasone compared with montelukast in terms of gain in ACDs (adjusted P = .02) and time to first exacerbation (adjusted P = .05). Increased baseline eNO levels predicted the differential treatment response for fluticasone regarding the gain in ACDs (adjusted P = .01). Prior inhaled corticosteroid (ICS) use (adjusted P = .01) and low PC(20) values (adjusted P = .03) each predicted the expected treatment benefit with fluticasone over montelukast regarding time to first exacerbation. No phenotypic characteristics predicted treatment benefits for montelukast over fluticasone for either outcome. CONCLUSIONS: Physicians treating children with a parental history of asthma, increased eNO levels, low PC(20) values, or a history of ICS use can expect the best long-term outcomes with ICS therapy compared with treatment with leukotriene receptor antagonists.

Impulse oscillometry versus spirometry in a long-term study of controller therapy for pediatric asthma.

BACKGROUND: Determination of the benefits and limitations of specific physiologic tests has not been well studied in long-term clinical pediatric trials. OBJECTIVE: We sought to determine the utility of impulse oscillometry in a long-term comparison of 3 controller regimens in children with persistent asthma. METHODS: Children 6 to 14 years of age with mild-to-moderate persistent asthma were characterized with oscillometry and spirometry before entry into a clinical trial and then serially during 48 weeks of therapy with either an inhaled corticosteroid, a combination inhaled corticosteroid with a long-acting beta-agonist, or a leukotriene receptor antagonist. RESULTS: The FEV(1)/forced vital capacity ratio, as well as the forced expiratory flow from 25% to 75% of forced vital capacity in terms of spirometric parameters and the reactance area (XA) from impulse oscillometry, appeared to complement information provided by FEV(1) when comparing the tests and factors that appeared to predict a response to treatment. XA was unique in that it, as distinct from spirometric variables, reflected ongoing improvement during the latter part of the trial. In general, improvements in XA during the latter part of the study occurred independently of indices of atopy and the level of airway responsiveness. CONCLUSION: Assessment of respiratory mechanics over time with oscillometry might offer additional insights into the response of asthmatic patients to therapy. In particular, the pattern of improvement seen in XA over the course of therapy suggests this test might detect alterations in airway mechanics not reflected by spirometry. The possibility that changes in XA reflect ongoing improvement in small airway function deserves additional study.

Long-term inhaled corticosteroids in preschool children at high risk for asthma.

BACKGROUND: It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma. METHODS: We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 mug twice daily) or masked placebo for two years, followed by a one-year period without study medication. The primary outcome was the proportion of episode-free days during the observation year. RESULTS: During the observation year, no significant differences were seen between the two groups in the proportion of episode-free days, the number of exacerbations, or lung function. During the treatment period, as compared with placebo use, use of the inhaled corticosteroid was associated with a greater proportion of episode-free days (P=0.006) and a lower rate of exacerbations (P<0.001) and of supplementary use of controller medication (P<0.001). In the inhaled-corticosteroid group, as compared with the placebo group, the mean increase in height was 1.1 cm less at 24 months (P<0.001), but by the end of the trial, the height increase was 0.7 cm less (P=0.008). During treatment, the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth, albeit temporarily and not progressively. CONCLUSIONS: In preschool children at high risk for asthma, two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year. These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued. (ClinicalTrials.gov number, NCT00272441.).

Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children.

BACKGROUND: Asthma exacerbations are a common cause of critical illness in children. OBJECTIVE: To determine factors associated with exacerbations in children with persistent asthma. METHODS: Regression modeling was used to identify historical, phenotypic, treatment, and time-dependent factors associated with the occurrence of exacerbations, defined by need for oral corticosteroids or emergency or hospital care in the 48-week Pediatric Asthma Controller Trial study. Children age 6 to 14 years with mild-to-moderate persistent asthma were randomized to receive either fluticasone propionate 100 microg twice daily (FP monotherapy), combination fluticasone 100 microg AM and salmeterol twice daily, or montelukast 5 mg once daily. RESULTS: Of the 285 participants randomized, 48% had 231 exacerbations. Using a multivariate analysis, which included numerous demographic, pulmonary, and inflammatory parameters, only a history of an asthma exacerbation requiring a systemic corticosteroid in the past year (odds ratio [OR], 2.10; P < .001) was associated with a subsequent exacerbation during the trial. During the trial, treatment with montelukast versus FP monotherapy (OR, 2.00; P = .005), season (spring, fall, or winter vs summer; P < or = .001), and average seasonal 5% reduction in AM peak expiratory flow (OR, 1.21; P = .01) were each associated with exacerbations. Changes in worsening of symptoms, beta-agonist use, and low peak expiratory flow track together before an exacerbation, but have poor positive predictive value of exacerbation. CONCLUSION: Children with mild-to-moderate persistent asthma with previous exacerbations are more likely to have a repeat exacerbation despite controller treatment. Inhaled corticosteroids are superior to montelukast at modifying the exacerbation risk. Available physiologic measures and biomarkers and diary card tracking are not reliable predictors of asthma exacerbations.

Markers of Differential Response to Inhaled Corticosteroid Treatment Among Children with Mild Persistent Asthma.

BACKGROUND: Inhaled corticosteroids are recommended as first-line therapy for children with mild persistent asthma; however, specific patient characteristics may modify the treatment response. OBJECTIVE: Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. METHODS: Children aged 6 to 18 years with mild persistent asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 µg of beclomethasone twice daily. Rescue treatment consisted of 40 µg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. RESULTS: Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/µL or more, and history of oral corticosteroid use in the year before enrollment. As measured by asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/µL or more, and incomplete run-in asthma control. CONCLUSIONS: Children with mild persistent asthma who have markers of atopic asthma or who have greater asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy.

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial.

BACKGROUND: More evidence is needed on which to base recommendations for treatment of mild-moderate persistent asthma in school-aged children. OBJECTIVE: The Pediatric Asthma Controller Trial (PACT) compared the effectiveness of 3 regimens in achieving asthma control. METHODS: A total of 285 children (ages 6-14 years) with mild-moderate persistent asthma on the basis of symptoms, and with FEV(1) >or= 80% predicted and methacholine FEV(1) PC(20) or= 80% predicted, confirming current guideline recommendations.

Atopic characteristics of children with recurrent wheezing at high risk for the development of childhood asthma.

BACKGROUND: Few studies have characterized the atopic profile of toddler-aged children with recurrent wheezing at high risk of the development of persistent asthma. Objective We sought to determine the atopic profile of toddler-aged children with frequent wheeze at high risk for the development of persistent asthma who either had a parental history of asthma, a personal history of atopic dermatitis, or both. METHODS: Participants enrolled in the Prevention of Early Asthma in Kids study (n = 285) on the basis of a modified Asthma Predictive Index were characterized on the basis of allergy and asthma questionnaire responses and allergy skin puncture test results. RESULTS: The majority of the children (60.7%, n = 148) were sensitized to either food or aeroallergens. Male children were significantly more likely to be sensitized to aeroallergens ( P = .03) and to have a blood eosinophil level of 4% or greater ( P = .03) and a total serum IgE level of greater than 100 IU/mL ( P = .0004). Additionally, eosinophilia and total serum IgE level had the strongest correlation with aeroallergen sensitization. CONCLUSION: The high prevalence of aeroallergen sensitization in this high-risk cohort suggests that aeroallergens might have an important role in the early development of asthma. As such, the Prevention of Early Asthma in Kids cohort appears to be an appropriate cohort in which to test whether early intervention with an inhaled corticosteroid can significantly attenuate, or perhaps even prevent, the allergic march from the initial stages of allergic sensitization to the subsequent development of asthma in toddlers with episodic wheezing.

The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.

Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising. In order to promote innovative research in asthma therapies, the National Heart, Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999. As its first study, the steering committee of the Childhood Asthma Research and Education Network designed a randomized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease. This communication presents the design of its first clinical trial, the Prevention of Asthma in Kids (PEAK) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial. Studies of the natural history of asthma have shown that, in persistent asthma, the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life. Therefore, in the Prevention of Asthma in Kids study, children 2 and 3 years old with a positive asthma predictive index were randomized to twice daily treatment with fluticasone 88 microg or placebo via metered-dose inhaler and Aerochamber for 2 years. The double blind treatment period was followed by a 1-year observational period. Lung function was measured by spirometry and oscillometry technique at 4-month intervals throughout the study. Bronchodilator reversibility and exhaled nitric oxide (ENO) studies were performed at the end of the treatment and observation periods. The primary outcome measure was the number of asthma-free days. Other secondary outcomes included number of exacerbations, use of asthma medications and lung function. These measures were chosen to reflect the progression of the disease from intermittent wheezing to persistent asthma and measurement of the extent of airflow limitation and airway reactivity.