bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SLI381 (Adderall XR) in Children With Attention-Deficit/Hyperactivity Disorder
Authors: Biederman Joseph , Lopez Frank A. , Boellner Samuel W. , Chandler Mark C. 
Published: August 2004

Objective. SLI381 (Adderall XR) is a 2-component extended-release capsule formulation of Adderall designed to produce a therapeutic effect that lasts throughout the day with 1 morning dose. The primary objective of this study was to assess the efficacy and safety of SLI381 compared with placebo in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children in a naturalistic school and home setting. A secondary objective was to assess the diurnal variation in responses based on morning and afternoon assessments.
Methods. A multicenter, randomized, double-blind, parallel-group, placebo-controlled trial was conducted at 47 sites. After a 1-week washout of any previous stimulant medication, patients were randomized to receive single-daily morning doses of placebo or SLI381 10 mg, 20 mg, or 30 mg for 3 weeks. Participants aged 6 to 12 years inclusive who satisfied Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria diagnosis of ADHD were included. The primary efficacy parameter was the Conners Global Index Scale for Teachers. Secondary efficacy parameters included the Conners Global Index Scale for Parents, the Clinical Global Impressions Scale for improvement, and the Parent Global Assessment for improvement. Safety was assessed by recording adverse events, laboratory tests, and vital signs at each visit during the study. Physical examinations and electrocardiograms were performed at the screening and the end of the study.
Results. Five hundred eighty-four children were randomized, 563 were included in the intent-to-treat population, and 509 completed the entire study. Intention-to-treat analysis of Conners Global Index Scale for Teachers and Conners Global Index Scale for Parents scores revealed significant improvement in morning, afternoon, and late afternoon behavior for all active treatment groups versus placebo. All active treatment groups showed significant dose-related improvement in behavior from baseline. Both the Clinical Global Impressions Scale for improvement and Parent Global Assessment for improvement showed all doses of SLI381 to be superior to placebo at treatment end and both confirmed the dose-response relationship between improvement and the SLI381 dose. The incidence of spontaneously reported adverse events was low and similar for active treatments and placebo.
Conclusions. SLI381 produced consistent, dose-related improvements on all measures of efficacy. The extended-release nature of the SLI381 formulation was shown by continued, significant improvement in afternoon assessments by teachers and afternoon and late afternoon assessments by parents. The time course and therapeutic effects of SLI381 suggests that this medication is an efficacious once-daily treatment for children with ADHD.
Behavior Change Counseling in the Emergency Department to Reduce Injury Risk: A Randomized, Controlled Trial
Authors: Johnston Brian D. , Rivara Frederick P. , Droesch RoseAnne M. , Dunn Chris , Copass Michael K. 
Published: August 2004

Objective. To determine whether a brief session of behavior change counseling (BCC), offered to injured adolescents in the emergency department (ED) as a therapeutic intervention, could be used to change injury-related risk behaviors and the risk of reinjury.
Study Design. A randomized, controlled trial.
Participants. Adolescents between 12 and 20 years old who were undergoing treatment for an injury in the ED and who were cognitively able to participate in the intervention.
Setting. An urban ED at a level 1 pediatric trauma center.
Intervention. Study participants completed a baseline risk behavior prevalence assessment. Participants were then randomly assigned to receive BCC or routine ED care. Those in the treatment group underwent a brief session of BCC with a study social worker focused on changing an identified injury-related risk behavior (seatbelt use, bicycle helmet use, driving after drinking, riding with an impaired driver, binge drinking, or carrying a weapon). Participants were recontacted 3 months and 6 months after enrollment to assess the prevalence of positive behavior change and the interim occurrence of medically treated injuries.
Results. We enrolled 631 participants (78% of those eligible) and obtained follow-up for 76% at 3 months and 75% at 6 months. The relative risk of a positive behavior change with respect to seatbelt use was 1.34 (95% confidence interval [CI]: 1.00, 1.79) at 3 months, favoring the intervention group. The relative risk for the same outcome was 1.47 (95% CI: 1.09, 1.96) at 6 months. A positive change in bicycle helmet use was 1.81 (95% CI: 1.02, 3.18) times more likely at 3 months and 2.00 (95% CI: 1.00, 4.00) times more likely at 6 months in the intervention group. There was no effect of the intervention on changes in other target behaviors. Over the 6-month follow-up period, the risk of reinjury requiring medical attention did not differ between treatment groups.
Conclusions. Brief BCC can be delivered to adolescents undergoing treatment for injury in the ED and can be used to address injury-related risk behaviors. The intervention was associated with a greater likelihood of positive behavior change in seatbelt and bicycle helmet use. This effect lasted over 6 months of follow-up. BCC was not associated with changes in other risk behaviors and could not be shown to significantly reduce the risk of reinjury.
Association of Antenatal and Postnatal Dexamethasone Exposure With Outcomes in Extremely Low Birth Weight Neonates
Authors: LeFlore Judy L. , Salhab Walid A. , Broyles R. Sue , Engle William D. 
Published: August 2004

Background. Recent studies of preterm neonates have indicated that antenatal dexamethasone (ADX) may have adverse effects on cranial ultrasound findings at the time of hospital discharge, including periventricular leukomalacia. Furthermore, both ADX and postnatal dexamethasone (PDX) may have adverse effects on subsequent neurodevelopmental outcome.
Objectives. 1) To assess the effects of ADX exposure on cranial ultrasound findings at the time of hospital discharge and 2) to evaluate the individual effects of ADX and/or PDX exposure on subsequent neurodevelopmental outcome in extremely low birth weight (ELBW) neonates in whom confounding risk factors known to influence outcome were controlled.
Methods. One hundred seventy-three ELBW (≤1000 g) neonates were studied using a prospectively collected database and hospital and clinic records. Study patients were assigned to 1 of 4 groups according to dexamethasone exposure: group I, no dexamethasone exposure; group II, ADX exposure to hasten fetal lung maturity; group III, PDX exposure for chronic lung disease; group IV, both ADX and PDX exposure. The 4 groups were compared using multinomial logistic regression or analysis of covariance to control for confounding variables. Primary outcome variables were cranial ultrasound findings at hospital discharge and results of developmental testing at 18 to 22 months’ corrected age (Bayley Scales of Infant Development).
Results. Cranial ultrasound results as well as Bayley Scales of Infant Development scores were similar in groups I and II and in groups III and IV. The likelihood of abnormal cranial ultrasound studies and lower scores on neurodevelopmental testing was greater in groups III and IV versus groups I and II. In this study, ADX did not seem to increase the risk of periventricular leukomalacia.
Conclusions. ADX exposure is not associated with an increase in abnormal cranial ultrasound findings in ELBW neonates. PDX exposure, but not ADX exposure, is associated with worse neurodevelopmental outcome in this population. These results are supportive of the recent statement by the American Academy of Pediatrics (Committee on Fetus and Newborn) and the Canadian Paediatric Society (Fetus and Newborn Committee) and emphasize that PDX should be used with caution in ELBW neonates.
Late-Onset Sepsis in Very Low Birth Weight Neonates: The Experience of the NICHD Neonatal Research Network
Authors: Stoll Barbara J. , Hansen Nellie , Fanaroff Avroy A. , Wright Linda L. , Carlo Waldemar A. , Ehrenkranz Richard A. , Lemons James A. , Donovan Edward F. , Stark Ann R. , Tyson Jon E. , Oh. William , Bauer Charles R. , Korones Sheldon B. , Shankaran Seetha , Laptook Abbot R. , Stevenson David K. , Papile Lu-Ann , Poole W. Kenneth 
Published: August 2004

Objective. Late-onset sepsis (occurring after 3 days of age) is an important problem in very low birth weight (VLBW) infants. To determine the current incidence of late-onset sepsis, risk factors for disease, and the impact of late-onset sepsis on subsequent hospital course, we evaluated a cohort of 6956 VLBW (401–1500 g) neonates admitted to the clinical centers of the National Institute of Child Health and Human Development Neonatal Research Network over a 2-year period (1998–2000).Methods. The National Institute of Child Health and Human Development Neonatal Research Network maintains a prospective registry of all VLBW neonates admitted to participating centers within 14 days of birth. Expanded infection surveillance was added in 1998.Results. Of 6215 infants who survived beyond 3 days, 1313 (21%) had 1 or more episodes of blood culture-proven late-onset sepsis. The vast majority of infections (70%) were caused by Gram-positive organisms, with coagulase-negative staphylococci accounting for 48% of infections. Rate of infection was inversely related to birth weight and gestational age. Complications of prematurity associated with an increased rate of late-onset sepsis included patent ductus arteriosus, prolonged ventilation, prolonged intravascular access, bronchopulmonary dysplasia, and necrotizing enterocolitis. Infants who developed late-onset sepsis had a significantly prolonged hospital stay (mean length of stay: 79 vs 60 days). They were significantly more likely to die than those who were uninfected (18% vs 7%), especially if they were infected with Gram-negative organisms (36%) or fungi (32%).Conclusions. Late-onset sepsis remains an important risk factor for death among VLBW preterm infants and for prolonged hospital stay among VLBW survivors. Strategies to reduce late-onset sepsis and its medical, social, and economic toll need to be addressed urgently.
Assessing Risk Factors for Obesity Between Childhood and Adolescence: I. Birth Weight, Childhood Adiposity, Parental Obesity, Insulin, and Leptin
Authors: Salbe Arline D. , Weyer Christian , Lindsay Robert S. , Ravussin Eric , Tataranni P. Antonio 
Published: August 2004

Objective. To assess the effects of body weight, body composition, parental obesity, and metabolic variables on the development of obesity in a large cohort of 5-year-old Native American children with a high propensity for obesity.
Methods. During the summer months of 1992 to 1995 and again 5 years later, 138 (65 boys and 73 girls) 5-year-old Pima Indian children were studied. Height; weight; body composition; parental obesity; and fasting plasma insulin, glucose, and leptin concentrations were determined at baseline and follow-up. Linear regression models were used to assess the effect of the baseline variables on the development of obesity.
Results. At both 5 and 10 years of age, Pima Indian children were heavier and fatter than an age- and gender-matched reference population. All anthropometric and metabolic variables tracked strongly from 5 to 10 years of age (r ≥ 0.70). The most significant determinant of percentage of body fat at 10 years of age was percentage of body fat at 5 years of age (R2 = 0.53). The combined effect of high maternal body mass index, elevated fasting plasma leptin concentrations, and low fasting plasma insulin concentrations at baseline explained an additional 4% of the total variance in adiposity at follow-up.
Conclusions. Although parental obesity and metabolic variables such as insulinemia and leptinemia at baseline account for a small percentage of the variance in adiposity at follow-up, early childhood obesity is the dominant predictor of obesity 5 years later. These results suggest that strategies to prevent childhood obesity must be initiated at a very early age.
Assessing Risk Factors for Obesity Between Childhood and Adolescence: II. Energy Metabolism and Physical Activity
Authors: Salbe Arline D. , Weyer Christian , Harper Inge , Lindsay Robert S. , Ravussin Eric , Tataranni P. Antonio 
Published: August 2004

Objective. To assess the effect of energy expenditure, including resting metabolic rate (RMR), total energy expenditure (TEE), and activity energy expenditure (AEE), as well as substrate oxidation (respiratory quotient [RQ]), on the development of obesity in a large cohort of Native American children with a high propensity for obesity.
Methods. During the summer months of 1992 to 1995 and again 5 years later, 138 (65 boys and 73 girls) 5-year-old Pima Indian children were studied. At baseline and follow-up, height and weight were measured; body composition was assessed with the use of 18O dilution; RMR and RQ were assessed with the use of indirect calorimetry; TEE was measured with the use of the doubly-labeled water method; and AEE was calculated (TEE − [RMR + 0.1 × TEE]). In addition, an activity questionnaire was used to assess participation in sporting activities as well as television viewing during the previous year. Linear regression models were used to assess the effects of the baseline variables on the development of obesity.
Results. Pima Indian children were markedly overweight at both 5 and 10 years of age. Cross-sectionally, percentage of body fat and body weight at 5 and 10 years of age were negatively correlated with sports participation and positively correlated with television viewing. Most important, there was a marked change in the correlation between body size and activity between 5 and 10 years of age: at age 5 years, weight was positively correlated with AEE and PAL, but at age 10 years, the correlation with AEE was lost and that with PAL was negative. However, prospectively, none of the variables measured at baseline was a predictor of percentage of body fat at age 10 years after adjustment for percentage of body fat at age 5 years.
Conclusions. At age 5 years, obesity is associated with decreased participation in sports and increased television viewing but not with a decreased PAL. At age 10 years, obesity is associated with decreased participation in sports, increased television viewing, and a decreased PAL, suggesting that a decrease in PAL in free-living conditions seems to follow, not precede, the development of obesity.
Trends in Childhood Asthma: Prevalence, Health Care Utilization, and Mortality
Authors: Akinbami Lara J. , Schoendorf Kenneth C. 
Published: August 2004

Objectives. Our objective was to use national data to produce a comprehensive description of trends in childhood asthma prevalence, health care utilization, and mortality to assess changes in the disease burden among US children.Methods. Five data sources from the National Center for Health Statistics were used to describe trends in asthma for children aged 0 to 17 years from 1980 to the most recent year for which data were available. These included the National Health Interview Survey (NHIS), the National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey, the National Hospital Discharge Survey, and the Mortality Component of the National Vital Statistics System.Results. Asthma prevalence increased by an average of 4.3% per year from 1980 to 1996, from 3.6% to 6.2%. The peak prevalence was 7.5% in 1995. In 1997, asthma attack prevalence was 5.4%, but changes in the NHIS design in 1997 preclude comparison to previous estimates. Asthma attack prevalence remained level from 1997 to 2000. After a decrease between 1980 and 1989, the asthma office visit rate increased by an average of 3.8% per year from 1989 to 1999. The asthma hospitalization rate grew by 1.4% per year from 1980 to 1999. Although childhood asthma deaths are rare, the asthma death rate increased by 3.4% per year from 1980 to 1998. Children aged 0 to 4 years had the largest increase in prevalence and had greater health care use, but adolescents had the highest mortality. The asthma burden was borne disproportionately by black children throughout the period. Racial disparities were largest for asthma hospitalizations and mortality: compared with white children, in 1998–1999, black children were &gt;3 times as likely to be hospitalized and in 1997–1998 &gt;4 times as likely to die from asthma.Conclusions. Recent data suggest that the burden from childhood asthma may have recently plateaued after several years of increasing, although additional years of data collection are necessary to confirm a change in trend. Racial and ethnic disparities remain large for asthma health care utilization and mortality.
Parental Impressions of the Benefits (Pros) and Barriers (Cons) of Follow-up Care After an Acute Emergency Department Visit for Children With Asthma
Authors: Smith Sharon R. , Highstein Gabrielle R. , Jaffe David M. , Fisher Edwin B. , Strunk Robert C. 
Published: August 2004

Objective. Asthma morbidity, with increasing emergency department (ED) visits, is prevalent among low-income, urban children. Follow-up care after ED visits is infrequent. We developed and evaluated an instrument that describes the parental benefits (pros) and barriers (cons) of obtaining follow-up care for interventions to promote follow-up.Methods. We enrolled a convenience sample of low-income, urban parents who brought their children to the ED for treatment of asthma. These parents rated 41 items about the pros and cons of making a follow-up visit. Principal component analysis was used to identify the underlying structure of the instrument.Results. One hundred forty-seven participants were interviewed in the ED. Principal component analysis retained 24 total items, which were identified by this sample as highly associated with deciding to take their child to a follow-up visit. Two types of pros were identified, informational and attitudinal, including “ask the doctor questions,” and “ children with asthma are healthier if they see their doctor regularly.” Two types of cons were identified, practical and attitudinal, including “I have to find transportation,” and “I don’t need to see the doctor unless my child is sick.” The mean total pro and con scores were 4.05 ± 0.63 and 1.73 ± 0.67, respectively.Conclusions. The pros and cons are not unidimensional. Even among those with infrequent follow-up, pros were endorsed more highly than cons. Programs that target these pros and cons may improve adherence to follow-up and regular care for low-income urban children.
Tics and Problem Behaviors in Schoolchildren: Prevalence, Characterization, and Associations
Authors: Snider Lisa A. , Seligman Laura D. , Ketchen Bethany R. , Levitt Sara J. , Bates Lauren R. , Garvey Marjorie A. , Swedo Susan E. 
Published: August 2004

Objective. Tic disorders are the most common movement disorder diagnosed in children and have symptoms that fluctuate in frequency and intensity over time. We conducted an 8-month longitudinal observational study to determine the variations in frequency of motor tics and associated problem behaviors.Methods. A total of 553 children, kindergarten through sixth grade, were observed monthly from November 1999 to June 2000 by 3 raters. Motor tics were recorded by location and rated for severity as none (0), mild (1), moderate (2), or severe (3). Problem behaviors were rated as absent (0), subclinical (1), or clinical (2) in each of 6 categories: disruptive, hyperactive, impulsive, aggressive, anxious, and distracted.Results. The monthly point prevalence of motor tics ranged from 3.2% to 9.6%, with an overall frequency of 24.4%. The monthly point prevalence of problem behaviors ranged from 2.6% to 11.0%, with an overall frequency of 25.7%. The incidence of motor tics and problem behaviors was significantly higher during the winter months of November through February, compared with the spring months of March through June (motor tics: z = 4.97; problem behaviors: z = 3.79). Motor tics were observed in 2 distinct patterns (isolated and persistent), which varied by the number of months present, gender ratio of affected children, severity of tic symptoms, and association with problem behaviors.Conclusions. Motor tics and problem behaviors are frequent occurrences among schoolchildren and seem to occur more frequently during the winter months. For most children, the tics were mild, observed on only 1 occasion, and were not accompanied by problem behaviors.
Health Status of Children After Admission for Injury
Authors: Aitken Mary E. , Tilford John M. , Barrett Kathleen W. , Parker James G. , Simpson Pippa , Landgraf Jeanne , Robbins James M. 
Published: August 2004

Objective. Injury is the major cause of death in children ages 1 to 19 in the United States and is a leading cause of morbidity. Few studies have described the impact of injuries on the health status of affected children over time or used newer, child-specific measures in this population. The objective of this study was to describe the health status of children in the 6 months after admission for injury using child-specific health status measures.
Methods. Injured children who were ages 3 to 18 years and admitted to an academic children’s hospital were evaluated at discharge and at 1 and 6 months after discharge with a battery of outcome measures. The Child Health Questionnaire (CHQ) measured health status. The scores on the Functional Independence Measure (FIM) or pediatric version of the FIM tracked physical function.
Results. A total of 195 children were enrolled. Boys outnumbered girls (67% vs 33%). Injury mechanisms and severity scores were typical of pediatric injury populations reported in other studies. Most (90%) children had at least 1 area of functional limitation by FIM at discharge, and 57% had some impairment at 1 month. By 6 months, 28% reported some limitation. At discharge, CHQ summary scores for the injury group were markedly depressed compared with normative populations. Differences in both physical health and psychosocial health summary scores between the injured and normal children persisted through 6 months of follow-up. Scores on 11 of 12 subscales were significantly below the normal population at discharge. This was particularly evident for bodily pain (injury group mean 49.1 vs normative mean 81.7) and parental impact-emotional (43.9 vs 80.3), and physical functioning (50.9 vs 96.1). Significant differences persisted in all subscales at 1 month and in 6 subscales at 6 months.
Conclusions. The CHQ provided useful information about the impact of injuries on children and their families over time. Significantly reduced scores in several domains of the CHQ highlight problem areas for injury patients, several of which persist through 6 months of follow-up. Low scores in areas of bodily pain and parental emotional burden suggest that improved management of these problems is required. Additional study of risk factors for persistent problems after injury may suggest ways to improve functional outcomes of injured children and reduce the impact on their families.