Growth hormone improves clinical status in prepubertal children with cystic fibrosis: results of a randomized controlled trial.

OBJECTIVES: We conducted a 1-year randomized controlled trial to test the hypothesis that growth hormone (GH) improves the clinical status of children with cystic fibrosis. STUDY DESIGN: Nineteen prepubertal children were randomized to control (NonTX, n = 9) or to daily injections of GH (0.3 mg/kg/wk) (GHTX, n = 10) for 1 year. Every 3 months height, weight, and lean tissue mass were measured. Caloric intake, resting energy expenditure, pulmonary function, and respiratory muscle strength were measured every 6 months, as were total number of hospitalizations and courses of outpatient intravenous antibiotics. RESULTS: The GHTX group had significantly greater height, height velocity (NonTX = 3.8 +/- 1.4 cm/y, GHTX = 8.1 +/- 2.4 cm/y; P =.002), weight, weight velocity (NonTX = 2.1 +/- 0.9 kg/y, GHTX = 4.5 +/- 1.1 kg/y; P =.004), and change in lean tissue mass (NonTX = 2.1 +/- 1.6 kg, GHTX = 4.7 +/- 1.7 kg; P =.01) analyzed by the Student t test. The GHTX group had significant improvement in delta forced vital capacity compared with the year before study, and respiratory muscle strength improved. The number of hospitalizations and outpatient intravenous antibiotic courses significantly decreased in the GHTX group but did not change in the NonTX group. No subject had development of cystic fibrosis-related diabetes. CONCLUSIONS: Results of the first randomized controlled trial of GH treatment in cystic fibrosis indicate that GH improves growth and clinical status.     

Theophylline versus terbutaline in treating critically ill children with status asthmaticus: a prospective, randomized, controlled trial.

OBJECTIVE: To compare the efficacy of theophylline, terbutaline, or theophylline combined with terbutaline treatment in critically ill children with status asthmaticus who are already receiving continuous nebulized albuterol and intravenous corticosteroids. DESIGN: Randomized, prospective, controlled, double-blind trial. SETTING: Pediatric intensive care unit of a tertiary-care children's medical center. PATIENTS: Forty critically ill children between the ages of 3 and 15 yrs with impending respiratory failure secondary to status asthmaticus. INTERVENTIONS: All patients received intravenous methylprednisolone and continuous nebulized albuterol. The three study groups received theophylline plus placebo (group 1), terbutaline plus placebo (group 2), or theophylline and terbutaline together (group 3). MEASUREMENTS AND MAIN RESULTS: Differences in baseline characteristics, change in clinical asthma score over time, length of pediatric intensive care unit stay, and incidence of adverse events were determined. The three study groups were similar in age, gender, race, asthma severity, and treatment. There were no differences in clinical asthma score over time, length of pediatric intensive care unit stay, or incidence of adverse events between the three groups, with the exception of a higher incidence of nausea in children in group 3. The median hospital cost of medication and theophylline blood levels was significantly lower in group 1 compared with groups 2 and 3 (280 US dollars vs. 3,908 US dollars vs. 4,045 US dollars, respectively, p < .0001). CONCLUSIONS: Theophylline, when added to continuous nebulized albuterol therapy and intravenous corticosteroids, is as effective as terbutaline in treating critically ill children with status asthmaticus. The addition of theophylline to baseline therapy is more cost-effective when compared with terbutaline alone or terbutaline and theophylline together. Theophylline should be considered for use early in the management of critically ill asthmatic children.     

Improving asthma outcomes and self-management behaviors of inner-city children: a randomized trial of the Health Buddy interactive device and an asthma diary

BACKGROUND: Asthma is an important cause of morbidity, absence from school, and use of health services among children. Computer-based educational programs can be designed to enhance children's self-management skills and to reduce adverse outcomes. OBJECTIVE: To assess the effectiveness of an interactive device programmed for the management of pediatric asthma. DESIGN: A randomized controlled trial (66 participants were in the intervention group and 68 were in the control group). SETTING: Interventions conducted at home and in an outpatient hospital clinic. PARTICIPANTS: Inner-city children aged 8 to 16 years diagnosed as having asthma by a physician. INTERVENTION: An asthma self-management and education program, the Health Buddy, designed to enable children to assess and monitor their asthma symptoms and quality of life and to transmit this information to health care providers (physicians, nurses, or other case managers) through a secure Web site. Control group participants used an asthma diary. MAIN OUTCOME MEASURES: Any limitation in activity was the primary outcome. Secondary outcomes included perceived asthma symptoms, absence from school, any peak flow reading in the yellow or red zone, and use of health services. RESULTS: After adjusting for covariates, the odds of having any limitation in activity during the 90-day trial were significantly (P =.03) lower for children randomized to the Health Buddy. The intervention group also was significantly (P =.01) less likely to report peak flow readings in the yellow or red zone or to make urgent calls to the hospital (P =.05). Self-care behaviors, which were important correlates of asthma outcomes, also improved far more for the intervention group. CONCLUSION: Compared with the asthma diary, monitoring asthma symptoms and functional status with the Health Buddy increases self-management skills and improves asthma outcomes.     

Efficacy of a home-made spacer with acute exacerbation of bronchial asthma : A randomized controlled trial

Metered dose inhaler (MDI) with spacer is the preferred method for administration of aerosolized medications in pediatric asthma. The expense of commercial spacers limits their use and indigenous alternatives have therefore been developed. Information on the clinical efficacy of home-made spacers is limited. This study was conducted to compare the efficacy of a valve-less home-made spacer with a commercial spacer in delivering salbutamolvia MDI in acute asthma. Asthmatic children aged 5–15 years who presented with an acute exacerbation to the pediatric chest clinic of a tertiary care hospital were enrolled in a single blinded randomized parallel group study. The study patients received 10 puffs of salbutamol (100(igJ puff)via MDI-home-made spacer or MDI-commercial spacer. Pre and post inhalation measurements of peak expiratory flow rate (PEFR), oxygen saturation (SaO2), respiratory rate (RR), pulse rate (PR) were made and compared. Sixty children were enrolled in the study, 31 were administered salbutamolvia the home-made spacer and 29via the commercial spacer. The median increase in PEFR was similar in both the groups (20.8% vs22.2%, p=0.4), clinical improvement being satisfactory in all patients. The valve-less home-made spacer is equally efficacious and cheaper than the commercial spacer in administering bronchodilators in acute exacerbations of asthma. Further studies on the efficacy of home-made spacer in delivery of inhaled steroids are needed.     

Improving attitudes toward the disabled: a randomized controlled trial of direct contact versus Kids-on-the-Block

Social interaction between able-bodied and disabled children (as in a "buddy" program) is known to improve children's attitudes toward handicapped peers. This randomized-factorial-design study evaluated the relative impact of two interventions--a buddy program and the Kids-on-the-Block (KOB) puppet program--singly and in combination. Outcomes included measures of attitudes, familiarity with disabled schoolmates, self-esteem, and parental attitude. The buddy program appeared to be a successful intervention. The KOB program alone had no measurable impact on any outcomes, compared with control children. Surprisingly, the combination of KOB and buddy programs produced a significantly smaller impact than the buddy program alone. The combination was also marginally significantly poorer than the change experienced by the control group. These results are discussed in relation to the probable dissonance between real disabled children and the puppets. Suggestions are advanced for possible strategies to enhance interventions to teach social interactional skills to able-bodied children.     

A randomized controlled trial on the effect of montelukast on sputum eosinophil cationic protein in children with corticosteroid-dependent asthma

Previous adult studies demonstrated the clinical efficacy of an additional treatment with leukotriene receptor antagonists on steroid-dependent asthma, but there is little knowledge about anti-inflammatory add-on effects within the lung. In this study, we hypothesized that steroid-treated children exhibit a decrease in bronchial inflammation in induced sputum under additional treatment with montelukast. Twenty-five asthmatic children aged 6 to 14 y, who had been taking inhaled corticosteroids (400-800 microg/d budesonide) regularly for at least 12 wk, were randomized to receive additional treatment with either montelukast (5 mg orally, once daily) or placebo over a 4-wk period. As primary efficacy variable, eosinophil cationic protein (ECP) in induced sputum as direct measurement of bronchial inflammation was assessed before and after treatment. To assure a baseline level of inflammation, an ECP concentration above 100 microg/L was required. Sputum eosinophil count, concentration of exhaled nitric oxide, urinary excretion of eosinophil protein X, and quality-of-life items were considered as secondary outcome variables. After treatment with montelukast, ECP in sputum was significantly reduced (montelukast: median -975 microg/L [5 to 95% confidence interval: -4295 to 583 microg/L]; placebo: 561 microg/L [-1335 to 3320 microg/L]; p < 0.01) and the quality-of-life score had significantly improved (p < 0.05) compared with placebo. Partly explained by low baseline levels, no statistically significant change in concentration of exhaled nitric oxide (p > 0.05), urinary excretion of eosinophil protein X (p > 0.05), or eosinophil count (p > 0.05) was found. In conclusion, add-on treatment with montelukast can suppress sputum ECP in children with steroid-dependent asthma, while at the same time an improvement in quality of life items occurs.