Prevalence of Prediabetes and Type 2 Diabetes in Children With Nonalcoholic Fatty Liver Disease.

IMPORTANCE: Nonalcoholic fatty liver disease (NAFLD) is a major chronic liver disease in children in the United States and is associated with insulin resistance. In adults, NAFLD is also associated with type 2 diabetes. To our knowledge, the prevalence of type 2 diabetes in children with NAFLD is unknown. OBJECTIVE: To determine the prevalence of type 2 diabetes and prediabetes in children with NAFLD and assess type 2 diabetes and prediabetes as risk factors for nonalcoholic steatohepatitis (NASH). DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, cross-sectional study at 12 pediatric clinical centers across the United States participating in the National Institute of Diabetes and Digestive and Kidney Diseases NASH Clinical Research Network. Children younger than 18 years with biopsy-confirmed NAFLD enrolled in the NASH Clinical Research Network. MAIN OUTCOMES AND MEASURES: The presence of type 2 diabetes and prediabetes as determined by American Diabetes Association screening criteria using clinical history and fasting laboratory values. RESULTS: There were 675 children with NAFLD included in the study with a mean age of 12.6 years and mean body mass index (calculated as weight in kilograms divided by height in meters squared) of 32.5. Most of the children were boys (480 of 675) and Hispanic (445 of 675).The estimated prevalence of prediabetes was 23.4% (95% CI, 20.2%-26.6%), and the estimated prevalence of type 2 diabetes was 6.5% (95% CI, 4.6%-8.4%). Girls with NAFLD had 1.6 (95% CI, 1.04-2.40) times greater odds of having prediabetes and 5.0 (95% CI, 2.49-9.98) times greater odds of having type 2 diabetes than boys with NAFLD. The prevalence of NASH was higher in those with type 2 diabetes (43.2%) compared with prediabetes (34.2%) or normal glucose (22%) (P < .001). The odds of having NASH were significantly higher in those with prediabetes (OR, 1.9; 95% CI, 1.21-2.9) or type 2 diabetes (OR, 3.1; 95% CI, 1.5-6.2) compared with those with normal glucose. CONCLUSIONS AND RELEVANCE: In this study, nearly 30% of children with NAFLD also had type 2 diabetes or prediabetes. These children had greater odds of having NASH and thus were at greater long-term risk for adverse hepatic outcomes.

Clinical Model for NASH and Advanced Fibrosis in Adult Patients With Diabetes and NAFLD: Guidelines for Referral in NAFLD.

OBJECTIVE: Approximately 18 million people in the U.S. have coexisting type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). It is not known who among these patients has nonalcoholic steatohepatitis (NASH) with advanced fibrosis. Therefore, we aimed to determine factors that are associated with both NASH and advanced fibrosis in patients with diabetes and NAFLD in order to identify who should be prioritized for referral to a hepatologist for further diagnostic evaluation and treatment. RESEARCH DESIGN AND METHODS: This study was derived from the NASH Clinical Research Network studies and included 1,249 patients with biopsy-proven NAFLD (including a model development cohort of 346 patients and an independent validation cohort of 100 patients with type 2 diabetes as defined by the American Diabetes Association criteria). Outcome measures were presence of NASH or advanced fibrosis (stage 3 or 4) using cross-validated, by jackknife method, multivariable-adjusted area under the receiver operating characteristic curve (AUROC) and 95% CI. RESULTS: The mean ± SD age and BMI of patients with diabetes and NAFLD was 52.5 ± 10.3 years and 35.8 ± 6.8 kg/m(2), respectively. The prevalence of NASH and advanced fibrosis was 69.2% and 41.0%, respectively. The model for NASH included white race, BMI, waist, alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, HbA1c, HOMA of insulin resistance, and ferritin with an AUROC of 0.80 (95% CI 0.75-0.84, P = 0.007). The specificity, sensitivity, negative predictive values (NPVs), and positive predictive values (PPVs) were 90.0%, 56.8%, 47.7%, and 93.2%, respectively, and the model correctly classified 67% of patients as having NASH. The model for predicting advanced fibrosis included age, Hispanic ethnicity, BMI, waist-to-hip ratio, hypertension, ALT-to-AST ratio, alkaline phosphatase, isolated abnormal alkaline phosphatase, bilirubin (total and direct), globulin, albumin, serum insulin, hematocrit, international normalized ratio, and platelet count with an AUROC of 0.80 (95% CI 0.76-0.85, P < 0.001). The specificity, sensitivity, NPV, and PPV were 90.0%, 57%, 75.1%, and 80.2%, respectively, and the model correctly classified 76.6% of patients as having advanced fibrosis. Results remained consistent for both models in the validation cohort. The proposed model performed better than the NAFLD fibrosis score in detecting advanced fibrosis. CONCLUSIONS: Routinely available clinical variables can be used to quantify the likelihood of NASH or advanced fibrosis in adult diabetic patients with NAFLD. The clinical models presented can be used to guide clinical decision making about referrals of patients with diabetes and NAFLD to hepatologists.

Longitudinal assessment of high blood pressure in children with nonalcoholic fatty liver disease.

OBJECTIVE: Nonalcoholic fatty liver disease (NAFLD) affects 9.6% of children and may put these children at elevated risk of high blood pressure and subsequent cardiovascular morbidity and mortality. Therefore, we sought to determine the prevalence of and risk factors for high blood pressure in children with NAFLD. METHODS: Cohort study performed by the NIDDK NASH Clinical Research Network. There were 484 children with NAFLD ages 2 to 17 at enrollment; 382 children were assessed both at enrollment and 48 weeks afterwards. The main outcomes were high blood pressure at baseline and persistent high blood pressure at both baseline and 48 weeks. RESULTS: Prevalence of high blood pressure at baseline was 35.8% and prevalence of persistent high blood pressure was 21.4%. Children with high blood pressure were significantly more likely to have worse steatosis than children without high blood pressure (mild 19.8% vs. 34.2%, moderate 35.0% vs. 30.7%, severe 45.2% vs. 35.1%; P = 0.003). Higher body mass index, low-density lipoprotein, and uric acid were independent risk factors for high blood pressure (Odds Ratios: 1.10 per kg/m2, 1.09 per 10 mg/dL, 1.25 per mg/dL, respectively). Compared to boys, girls with NAFLD were significantly more likely to have persistent high blood pressure (28.4% vs.18.9%; P = 0.05). CONCLUSIONS: In conclusion, NAFLD is a common clinical problem that places children at substantial risk for high blood pressure, which may often go undiagnosed. Thus blood pressure evaluation, control, and monitoring should be an integral component of the clinical management of children with NAFLD.

Factors associated with completion of a behavioral intervention for caregivers of urban children with asthma.

BACKGROUND: Rates of preventive follow-up asthma care after an acute emergency department (ED) visit are low among inner-city children. We implemented a novel behavioral asthma intervention, Pediatric Asthma Alert (PAAL) intervention, to improve outpatient follow-up and preventive care for urban children with a recent ED visit for asthma. OBJECTIVE: The objective of this article is to describe the PAAL intervention and examine factors associated with intervention completers and noncompleters. METHODS: Children with persistent asthma and recurrent ED visits (N = 300) were enrolled in a randomized controlled trial of the PAAL intervention that included two home visits and a facilitated follow-up visit with the child's primary care provider (PCP). Children were categorized as intervention completers, that is, completed home and PCP visits compared with noncompleters, who completed at least one home visit but did not complete the PCP visit. Using chi-square test of independence, analysis of variance, and multiple logistic regression, the intervention completion status was examined by several sociodemographic, health, and caregiver psychological variables. RESULTS: Children were African-American (95%), Medicaid insured (91%), and young (aged 3-5 years, 56%). Overall, 71% of children randomized to the intervention successfully completed all home and PCP visits (completers). Factors significantly associated with completing the intervention included younger age (age 3-5 years: completers, 65.4%; noncompleters, 34.1%; p < .001) and having an asthma action plan in the home at baseline (completers: 40%; noncompleters: 21%; p = .02). In a logistic regression model, younger child age, having an asthma action plan, and lower caregiver daily asthma stress were significantly associated with successful completion of the intervention. CONCLUSIONS: The majority of caregivers of high-risk children with asthma were successfully engaged in this home and PCP-based intervention. Caregivers of older children with asthma and those with high stress may need additional support for program completion. Further, the lack of an asthma action plan may be a marker of preexisting barriers to preventive care.

Factors associated with second-hand smoke exposure in young inner-city children with asthma.

OBJECTIVES: To examine the association of social and environmental factors with levels of second-hand smoke (SHS) exposure, as measured by salivary cotinine, in young inner-city children with asthma. METHODS: We used data drawn from a home-based behavioral intervention for young high-risk children with persistent asthma post-emergency department (ED) treatment (N = 198). SHS exposure was measured by salivary cotinine and caregiver reports. Caregiver demographic and psychological functioning, household smoking behavior, and asthma morbidity were compared with child cotinine concentrations. Chi-square and ANOVA tests and multivariate regression models were used to determine the association of cotinine concentrations with household smoking behavior and asthma morbidity. RESULTS: Over half (53%) of the children had cotinine levels compatible with SHS exposure and mean cotinine concentrations were high at 2.42 ng/ml (SD 3.2). The caregiver was the predominant smoker in the home (57%) and 63% reported a total home smoking ban. Preschool aged children and those with caregivers reporting depressive symptoms and high stress had higher cotinine concentrations than their counterparts. Among children living in a home with a total home smoking ban, younger children had significantly higher mean cotinine concentrations than older children (cotinine: 3-5 year olds, 2.24 ng/ml (SD 3.5); 6-10 year olds, 0.63 ng/ml (SD 1.0); p < .05). In multivariate models, the factors most strongly associated with high child cotinine concentrations were increased number of household smokers (ß = 0.24) and younger child age (3-5 years) (ß = 0.23; p < .001, R(2) = 0.35). CONCLUSION: Over half of the young inner-city children with asthma were exposed to SHS, and caregivers are the predominant household smokers. Younger children and children with depressed and stressed caregivers are at significant risk of smoke exposures, even when a household smoking ban is reported. Further advocacy for these high-risk children is needed to help caregivers quit and to mitigate smoke exposure.

Influence of caregiver and provider communication on symptom days and medication use for inner-city children with asthma.

BACKGROUND: Effective pediatric guideline-based asthma care requires the caregiver to accurately relay the child's symptom frequency, pattern of rescue and controller medication use, and level of asthma control to the child's primary care clinician. OBJECTIVE: This study evaluated the longitudinal effects of a caregiver-clinician asthma communication education intervention (ACE) relative to an asthma education control group (CON) on symptom days and controller medication use in inner-city children with asthma. PARTICIPANTS AND METHODS: 231 inner-city children with asthma, recruited from urban pediatric emergency departments (EDs) and community practices, were followed for 12 months. Data included number of symptom days and nights, ED visits, hospitalizations, presence of limited activity, and controller medication use over 12 months. Pharmacy records were used to calculate controller to total asthma medication ratios as a proxy of appropriate controller medication use. Multivariate logistic regression models were used to identify factors associated with number of symptom days and nights over the past 30 days at the 12-month follow-up. RESULTS: Most caregivers rated the communication with their child's clinician as high. Unadjusted and adjusted rates of symptom days and nights did not differ by group at follow-up. ACE children tended towards a higher controller to total medication ratio at 12 months as compared to CON children (mean ratio: ACE: 0.54, SD 0.3; CON, 0.45, SD 0.4; p = .07). Activity limitation due to asthma and persistent asthma severity were the only factors significantly associated with reporting any symptom day within the past 30 days, adjusting for treatment group, number of oral corticosteroid courses and number of clinician visits in the last 6 months, seasonality, insurance type, and controller to total asthma medication ratio covariates. CONCLUSION: A home-based caregiver asthma communication educational intervention was not associated with decreased symptom days. However, a trend was noted in higher controller to total medication ratios in the intervention group. Inner-city caregivers of children with asthma may require a health systems approach to help convey the child's asthma health information to their clinician.

Life events, chronic stressors, and depressive symptoms in low-income urban mothers with asthmatic children.

OBJECTIVE: This secondary data analysis study examines the relationship between maternal sociodemographic variables, life events, chronic stressors, including asthma control and management and environmental stressors, and maternal depression. DESIGN: Cross-sectional descriptive design study consisting of baseline data from participants enrolled in a randomized asthma communication educational intervention trial. SAMPLE: 201 mothers of children with asthma (ages 6-12), recruited from community pediatric practices and emergency departments of 2 urban university hospitals. MEASUREMENT: Life events were measured using standardized items. Chronic stressors were measured using items from the International Asthma and Allergies in Childhood study and maternal and child exposure to violence. Depressive symptoms were assessed with the Center for Epidemiologic Studies-Depression scale. RESULTS: Close to 25% of the mothers had high depressive symptoms. In separate multiple logistic regression models, education (adjusted odds ratio [AOR]=2.62; 95% confidence interval [CI]=1.07, 6.39) or unemployment (AOR=2.38; 95% CI=1.16, 4.90) and the use of quick relief medications (AOR=2.74; 95% CI=1.33, 5.66) for asthma were positively associated with depressive symptoms. CONCLUSIONS: Implications include the need to assess maternal depressive symptoms of mothers of children with asthma, in order to improve asthma management for low-income urban children.

Seasonal patterns of controller and rescue medication dispensed in underserved children with asthma.

OBJECTIVE: To determine whether temporal trends exist for short-acting beta agonist (SABA), oral corticosteroid (OCS), and anti-inflammatory prescription fills in children with persistent asthma. METHOD: This was a longitudinal analysis of pharmacy record data and health information data obtained by parent report over 12 months for children with persistent asthma 2 to 9 years of age. Eligible children had to report current nebulizer use and one or more emergency department visits or hospitalizations within the past 12 months. RESULTS: Children were primarily African-American (89%), male (64%), received Medicaid health insurance (82%), and were a mean age of 4.5 years (SD 2.1). Few families (11%) reported any problems paying for their child's asthma medications at baseline or at the 12-month follow-up. There was a high degree of association between filling a rescue (SABA or OCS) and controller (leukotriene modifier, inhaled corticosteroid, cromolyn) medication during the same month for all months with Pearson's correlation coefficients ranging from a low of 0.28 for October to a high of 0.53 in September. Short-acting beta agonist fills were significantly more likely to be filled concurrently with inhaled corticosteroid fills. However, significantly fewer prescription fills were obtained in the summer months with an acceleration of medication fills in September through December and an increase in early spring. CONCLUSIONS: There was a summer decline in both inhaled corticosteroid and SABA fills. Timing of asthma monitoring visits to occur before peak prescription fill months, i.e., August and December for an asthma "tune-up," theoretically could improve asthma control. During these primary care visits children could benefit from more intensive monitoring of medication use including monitoring lung function, frequency of prescription refills, and assessment of medication device technique to ensure that an effective dose of medication is adequately delivered to the respiratory tract. Additionally, scheduling non-urgent asthma care visits at pre-peak prescription fill months can take advantage of "step down" during decreased symptom periods and when appropriate restart daily controller medications to "step up" prior to peak asthma periods.

Patterns of inhaled antiinflammatory medication use in young underserved children with asthma.

BACKGROUND: Asthma guidelines advocate inhaled corticosteroids as the cornerstone treatment of persistent asthma, yet several studies report underuse of inhaled corticosteroids in children with persistent asthma. Moreover, few studies use objective pharmacy data as a measure of drug availability of asthma medications. We examined factors associated with the use of inhaled corticosteroids in young underserved children with persistent asthma using pharmacy records as their source of asthma medications. METHODS: This was a cross-sectional analysis of questionnaire and pharmacy record data over a 12-month period from participants enrolled in a randomized clinical trial of a nebulizer educational intervention. RESULTS: Although exposure to > or = 1 inhaled corticosteroids refill was high at 72%, 1 of 5 children with persistent asthma had either no medication or only short-acting beta agonist fills for 12 months. Only 20% of children obtained > or = 6 inhaled corticosteroids fills over 12 months. Obtaining > or = 3 inhaled corticosteroids fills over 12 months was significantly associated with an increase in short-acting beta agonist fills and receiving specialty care in the regression models while controlling for child age, asthma severity, number of emergency department visits, having an asthma action plan, and seeking preventive care for the child's asthma. CONCLUSIONS: Overreliance on short-acting beta agonist and underuse of inhaled corticosteroid medications was common in this group of young children with persistent asthma. Only one fifth of children obtained sufficient controller medication fills.

Pharmacy fill patterns in young urban children with persistent asthma.

BACKGROUND: Medication adherence impacts healthcare utilization. Pharmacy records are useful to establish fill patterns. OBJECTIVE: Use pharmacy records to establish medication patterns fill patterns for comparison to healthcare utilization. Methods. Pharmacy records of 175 children with persistent asthma were collected and compared to healthcare utilization. RESULTS: Majority of subjects had significant healthcare utilization, low numbers of rescue medications, and poor controller medication fill rates. Those with more rescue medications had more healthcare utilization and more controller medications. CONCLUSIONS: Pharmacy fill patterns demonstrate few rescue and/or controller medication fills. Those with more rescue medications reported increased healthcare utilization despite controller medications.

Effectiveness of nebulizer use-targeted asthma education on underserved children with asthma.

OBJECTIVE: To determine the effectiveness of a home-based asthma education intervention in increasing appropriate nebulizer use and reducing symptom frequency, emergency department (ED) visits, and hospitalizations over 12 months. DESIGN: A randomized clinical trial. Settings Pediatric primary care, pulmonary/allergy, and ED practices associated with the University of Maryland Medical System and The Johns Hopkins Hospital, Baltimore. PARTICIPANTS: Children with persistent asthma, aged 2 to 9 years, with regular nebulizer use and an ED visit or hospitalization within the past 12 months. Children were randomized into the intervention (n = 110) or control (n = 111) group. Follow-up data were available for 95 intervention and 86 control children. INTERVENTION: Home-based asthma education, including symptom recognition, home treatment of acute symptoms, appropriate asthma medication, and nebulizer practice. MAIN OUTCOME MEASURES: Estimates of mean differences in asthma symptom frequency, number of ED visits and hospitalizations and appropriate quick relief, controller medication, and nebulizer practice over 12 months. RESULTS: Of the 221 children, 181 (81.9%) completed the study. There were no significant differences in home nebulizer practice, asthma morbidity, ED visits, or hospitalizations between groups (P range, .11-.79). Although most children received appropriate nonurgent asthma care (mean, 2 visits per 6 months), more than one third of all children received at least 6 quick-relief medication prescriptions during 12 months, with no difference by group. CONCLUSIONS: A nebulizer education intervention had no effect on asthma severity or health care use. Of concern is the high quick-relief and low controller medication use in young children with asthma seen nearly every 3 months for nonurgent care.

Relationship between performance measurement and accreditation: implications for quality of care and patient safety.

This study examined the association between the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation scores and the Agency for Healthcare Research and Quality's Inpatient Quality Indicators and Patient Safety Indicators (IQIs/PSIs). JCAHO accreditation data from 1997 to 1999 were matched with institutional IQI/PSI performance from 24 states in the Healthcare Cost and Utilization Project. Most institutions scored high on JCAHO measures despite IQI/PSI performance variation with no significant relationship between them. Principal component analysis found 1 factor each of the IQIs/PSIs that explained the majority of variance on the IQIs/PSIs. Worse performance on the PSI factor was associated with worse performance on JCAHO scores (P=.02). No significant relationships existed between JCAHO categorical accreditation decisions and IQI/PSI performance. Few relationships exist between JCAHO scores and IQI/PSI performance. There is a need to continuously reevaluate all measurement tools to ensure they are providing the public with reliable, consistent information about health care quality and safety.

Monitoring nebulizer use in children: comparison of electronic and asthma diary data.

BACKGROUND: Measurement of nebulizer medication adherence that relies on self-report of medication use is subject to recall bias and increased patient burden. Electronic monitoring of nebulizer medication use is relatively new technology and provides an objective measure of nebulizer use. OBJECTIVE: To examine levels of agreement for nebulizer use between self-report on diary cards and electronic monitor data in young inner-city children with asthma. METHODS: Of 221 enrolled children with persistent asthma, 157 (71%) provided 12 weeks of diary card and nebulizer monitor recordings that were matched by date across days and by patient. Concordance, sensitivity, specificity, and kappa coefficients were calculated between self-report and electronic data. RESULTS: The children were predominantly African American (89%) and male (66%), with a mean age of 4.6 years. Their persistent asthma was categorized as mild (61%) or moderate to severe (35%). Concordance between diary and electronic data was 85%, with overreporting on diary cards noted on 15% of the total days. Sensitivity of the diary data relative to the electronic data ranged from 0.80 to 0.91 during the 12-week study. Diary return rates decreased from 75% during the initial 3 weeks to 44% at 12 weeks. CONCLUSIONS: Electronic monitoring of nebulizer use provides a more precise measure of long-term medication use than does self-report on diary cards, and it is feasible for use in high-risk populations. However, diary cards seem to be a valid alternative for short-term monitoring of nebulizer use, resulting in only a slight overestimation of medication use.

Episiotomy versus fetal manipulation in managing severe shoulder dystocia: a comparison of outcomes.

OBJECTIVE: In severe shoulder dystocia, when initial maneuvers fail, either episiotomy or fetal manipulation (Rubin, Woods' screw, or posterior arm release) is recommended. We sought to compare maternal and neonatal outcomes between severe shoulder dystocia deliveries managed with episiotomy versus fetal manipulation. STUDY DESIGN: We identified severe shoulder dystocia deliveries from three databases: all shoulder dystocia deliveries (1993-2003 and 1994-1997) from two teaching institutions and litigated cases of shoulder dystocia-associated permanent brachial plexus palsy from multiple U.S. institutions. Pair-wise comparisons were made among three groups of deliveries: those managed by fetal manipulation without episiotomy (fetal manipulation-only), those managed by episiotomy without fetal manipulation (episiotomy-only), and those managed with both (episiotomy + fetal manipulation). Rates of brachial plexus palsy, neonatal depression, and anal sphincter trauma were compared among groups using chi 2 , with significance at P < .05. RESULTS: Among episiotomy-only, 13 of 22 (59.1%) sustained brachial plexus palsy, compared with 20 of 57 (35.1%) among fetal manipulation-only (P = .05). Twenty-eight of 48 (58.3%) in episiotomy + fetal manipulation had brachial plexus palsy, which did not differ from episiotomy-only (P = .95) but was higher than fetal manipulation-only (P = .02), suggesting that the addition of episiotomy conferred no benefit in averting neonatal injury. Anal sphincter trauma was significantly more common among episiotomy-only and episiotomy + fetal manipulation, compared with fetal manipulation-only. CONCLUSION: In severe shoulder dystocia, if fetal manipulation can be performed without episiotomy, severe perineal trauma can be averted without incurring greater risk of brachial plexus palsy.

Asthma management practices at home in young inner-city children.

Information on parental asthma management practices for young children is sparse. The objective of this article is to determine if specific caregiver asthma management practices for children were associated with children's asthma morbidity. Caregivers of 100 inner-city children diagnosed with persistent asthma and participating in an ongoing asthma intervention study were enrolled and interviewed to ascertain measures of asthma morbidity, medication use, health care use (acute and primary care), and asthma management practices. Overall, asthma morbidity was high with almost two thirds of caregivers reporting their child having one or more emergency department visits within the last 6 months and 63% receiving specialty care for their asthma. Appropriate medication use was reported predominantly as albuterol and inhaled steroids (78%). However, only 42% of caregivers reported administering asthma medicines when their child starts to cough and less than half (39%) reported having an asthma action plan. There were no significant differences by asthma severity level for any asthma management practice. In conclusion, caregivers lack knowledge regarding cough as an early asthma symptom. Caregivers should be encouraged to review asthma action plans with health care providers at each medical encounter.

Growth and bone density in children with mild-moderate asthma: a cross-sectional study in children entering the Childhood Asthma Management Program (CAMP).

OBJECTIVES: We sought to determine whether mild-moderate persistent asthma sufficient to produce a decrease in baseline lung function is associated with an adverse effect on growth and bone mineral density (BMD) in children. METHODS: This was a cross-sectional study of 1041 children, 5 to 12 years old (32% ethnic/racial minorities and 40% female), enrolled into the Childhood Asthma Management Program (CAMP). Measures of asthma severity included: Spirometry; bronchial hyperresponsiveness; duration of asthma symptoms; and symptom-based assessment of severity. Multiple regression analyses were used to relate the asthma severity on the primary outcome variables: Height by stadiometry and BMD by dual energy radiographic absorptiometry. RESULTS: The mean +/- SD height percentile was 56.0 +/- 28.5 percentile for the population. The only significant relationship between asthma severity and height percentile was with methacholine bronchoprovocation in girls (beta 2.98, P =.019, covariate multiple regression). The mean +/- SD BMD was 0.65 +/- 0.10 g/cm(2) for the population. The past use of corticosteroids did not adversely affect either growth or BMD. CONCLUSIONS: We found that mild-moderate asthma of as long as 4 to 7 years duration in children does not produce an adverse effect on linear growth or BMD.

Long-term effects of budesonide or nedocromil in children with asthma.

BACKGROUND: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is limited information on their long-term use. METHODS: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 microg of budesonide (311 children), 8 mg of nedocromil (312 children), or placebo (418 children) twice daily. We treated the participants for four to six years. All children used albuterol for asthma symptoms. RESULTS: There was no significant difference between either treatment and placebo in the primary outcome, the degree of change in the forced expiratory volume in one second (FEV1, expressed as a percentage of the predicted value) after the administration of a bronchodilator. As compared with the children assigned to placebo, the children assigned to receive budesonide had a significantly smaller decline in the ratio of FEV1 to forced vital capacity (FVC, expressed as a percentage) before the administration of a bronchodilator (decline in FEV1:FVC, 0.2 percent vs. 1.8 percent). The children given budesonide also had lower airway responsiveness to methacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater reduction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications were needed. As compared with placebo, nedocromil significantly reduced urgent care visits (16 vs. 22 per 100 person-years) and courses of prednisone. The mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocromil and placebo groups. CONCLUSIONS: In children with mild-to-moderate asthma, neither budesonide nor nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of asthma than placebo or nedocromil. The side effects of budesonide are limited to a small, transient reduction in growth velocity.