Pediatrics
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Randomized Controlled Trial Comparative Study Clinical Trial
Asthma morbidity after the short-term use of ibuprofen in children.
To test the hypothesis that short-term use of ibuprofen increases asthma morbidity in children. ⋯ Rather than supporting the hypothesis that ibuprofen increases asthma morbidity among children who are not known to be sensitive to aspirin or other nonsteroidal antiinflammatory drugs, these data suggest that compared with acetaminophen, ibuprofen may reduce such risks. Whether the observed difference in morbidity according to treatment group is attributable to increased risk after acetaminophen use or a decrease after ibuprofen cannot be determined. These data provide evidence of the relative safety of ibuprofen use in children with asthma.
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Randomized Controlled Trial Comparative Study Clinical Trial
The behavioral impact of growth hormone treatment for children and adolescents with Prader-Willi syndrome: a 2-year, controlled study.
Prader-Willi syndrome (PWS) is characterized by obesity, hypotonia, hypogonadism, hyperphagia, short stature, and a neurobehavioral profile that includes cognitive deficits, learning problems, and behavioral difficulties that increase in both quantity and severity over time. PWS results from an alteration in the molecular composition of a critical region of C#15q. Morbid obesity resulting from hyperphagia is amplified by decreased energy expenditure and reduced physical activity. The hyperphagia has proven refractory to all psychopharmocologic intervention; the behavioral components are equally resistant to psychotropic intervention. PWS patients' body composition resembles that of individuals with growth hormone (GH) deficiency, including short stature and reduced lean body mass with concomitant increased fat mass. We hypothesized that GH administration to children with PWS, in addition to stimulating linear growth, would improve body composition, increase energy expenditure and fat utilization, and improve muscle strength, physical agility, and pulmonary function. Two recent reports from this study document significant positive effects of GH treatment on these children's physical parameters measured in a 2-year, controlled study. However, the behavioral impact of GH treatment in this population remains incompletely described. A psychosocial burden, including emotional, behavioral, and cognitive disturbances associated with short stature, has been previously described in a non-PWS population with GH deficiency and idiopathic short stature. An impaired quality of life and psychosocial status is also documented in otherwise normal adults with GH deficiency. In both populations, growth hormone replacement therapy (GHRT) is reported to improve alertness, activity level, endurance, irritability, tendency to worry, and extroversion resulting in better personal relationships with fewer conflicts. This report focuses on that portion of the study investigating the behavioral and psychosocial outcomes accompanying increased stature and improved physical status for persons with PWS treated with GHRT. We hypothesized that, as in other populations, GHRT for persons with PWS would have a significant positive effect on their psychosocial status as well as an improvement in their growth parameters. ⋯ Both between-group and within-group contrasts were computed for baseline, 12 (time 1) and 24 month (time 2) measures. Because behavioral deterioration, as well as improvement, was a possibility, a 2-tailed hypothesis test was used for all comparisons. No differences were found between treatment and control groups, nor within groups across measurement points for attentional symptoms, anxiety, obsessive-compulsive complex, violence, or psychotic symptoms. Similarly, no differences were noted between groups on depressive symptoms; however, a significant positive effect (reduction of depressive symptoms) was noted for the treatment group from baseline to time 1, and was retained at time 2. The group was divided by age, with those 11.0 years and younger comprising one group and those older the second group. This analysis indicated that the major reduction in depressive symptoms occurred in those over 11 years old. When divided by age, a second unexpected finding emerged. There was a significant increase in attention-deficit/hyperactivity disorder symptoms from baseline to 24 months in those children 11 and under, independent of treatment status. The groups were subsequently further broken down by sex and by genetic status (deletion versus disomy) with no significant findings. At no time was the expected behavioral deterioration reported. We conclude that in addition to the previously detailed improvements in physical parameters for these children, behavioral improvement, including a lack of predictable behavioral deterioration during the treatment period, is a strong argument for the use of GHRT for this difficult syndrome.
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Randomized Controlled Trial Clinical Trial
A randomized trial of moderately early low-dose dexamethasone therapy in very low birth weight infants: dynamic pulmonary mechanics, oxygenation, and ventilation.
Dexamethasone is used in very low birth weight (VLBW) ventilator-dependent infants to prevent or decrease the severity of chronic lung disease. We reported a significant increase in respiratory compliance during a 7-day weaning course of moderately early dexamethasone therapy (0.5 mg/kg/d) in VLBW infants, along with a shorter duration of mechanical ventilation and O2 supplementation. Although 0.5 mg/kg/d has been the most commonly used dose in preterm infants, the use of a lower dose of dexamethasone may reduce potential adverse effects of steroid therapy. Quantification of dynamic pulmonary mechanics in VLBW infants who receive low-dose dexamethasone has not been reported. The objective of this study was to compare the effect of 2 dose regimens of dexamethasone on dynamic pulmonary mechanics, mean airway pressure (MAP), and fractional inspired oxygen concentration (Fio2) in intubated VLBW infants who were at risk for chronic lung disease. ⋯ Our findings indicate that 1) comparable significant increases in Crs are present in the low-dose dexamethasone as well as the high-dose dexamethasone groups on days 2, 5, and 7 of steroid therapy; and 2) MAP and Fio2 are significantly decreased during dexamethasone therapy in both groups of infants. We conclude that low-dose and high-dose dexamethasone, as used in this study, have comparable beneficial effects on dynamic pulmonary mechanics and subsequently on oxygen requirement and applied ventilatory support in VLBW infants.