Pediatrics
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study).
The objective of this study was to evaluate differences in the pharmacodynamic (PD) profile of 2 second-generation extended-release (ER) formulations of methylphenidate (MPH): Metadate CD (MCD; methylphenidate HCl, US Pharmacopeia) extended-release capsules, CII, and Concerta (CON; methylphenidate HCl) extended-release tablets, CII. Little empirical information exists to help the clinician compare the PD effects of the available ER formulations on attention and behavior. Previous studies have shown that the near-equal doses of MCD and CON provide equivalent, total exposure to MPH as measured by area under the plasma concentration time curve, yet their pharmacokinetic (PK) plasma concentration versus time profiles are different. We previously offered a theoretical PK/PD account of the similarities and differences among available ER formulations based on the hypothesis that all formulations produce effects related to MPH delivered by 2 processes: 1) an initial bolus dose of immediate-release (IR) MPH that is expected to achieve peak plasma concentration in the early morning and have rapid onset of efficacy within 2 hours of dosing, which for the MCD capsule is delivered by 30% of the total daily dose as uncoated beads and for the CON tablet is delivered by an overcoat of 22% of the total daily dose; and 2) an extended, controlled delivery of ER MPH that is expected to achieve peak plasma concentrations in the afternoon to maintain efficacy for a programmed period of time after the peak of the initial bolus, which for the MCD capsule is delivered by polymer-coated beads and for the CON tablet by an osmotic-release oral system. According to this PK/PD model, clinical superiority is expected at any point in time for the formulation with the highest MPH plasma concentration. ⋯ Once-daily doses of MCD and CON produced statistically significantly different PD effects on surrogate measures of behavior and performance among children with attention-deficit/hyperactivity disorder in the laboratory school setting. As predicted by the PK/PD model, superiority at any point in time was achieved by the formulation with the highest expected plasma MPH concentration.
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Randomized Controlled Trial Comparative Study Clinical Trial
An evaluation of two procedures for training skills to prevent gun play in children.
Unintentional firearm injuries threaten the safety of children in the United States. Despite the occurrence of these injuries, few studies have evaluated the effectiveness of child-based programs designed to teach children gun-safety skills. This study compared 2 programs that were designed to reduce gun play in preschool children. ⋯ Existing programs are insufficient for teaching gun-safety skills to children. Programs that use active learning strategies (modeling, rehearsal, and feedback) are more effective for teaching gun-safety skills as assessed by supervised role plays but still failed to teach the children to use the skills outside the context of the training session. More research is needed to determine the most effective way to promote the use of the skills outside the training session.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomized, controlled trial comparing two different continuous positive airway pressure systems for the successful extubation of extremely low birth weight infants.
To determine whether the use of the Infant Flow continuous positive airway pressure (IF CPAP) system reduces the rate of extubation failure among extremely low birth weight (ELBW) infants (infants with birth weight <1000 g) when compared with conventional CPAP delivered with a conventional ventilator and nasal prongs. ⋯ Extubation failure is a common problem, occurring in nearly 40% of ELBW infants who require mechanical ventilation. IF CPAP was as effective but no more effective than conventional CPAP in preventing extubation failure among ELBW infants. New strategies are needed to identify predictors of extubation success and to treat apnea/bradycardia, the most common cause of extubation failure, thereby reducing the likelihood of prolonged intubation in this high-risk cohort of premature infants.
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Randomized Controlled Trial Comparative Study Clinical Trial
Low glycemic index breakfasts and reduced food intake in preadolescent children.
Recent reports have suggested that a low glycemic index (GI) diet may have a role in the management of obesity through its ability to increase the satiety value of food and modulate appetite. To date, no long-term clinical trials have examined the effect of dietary GI on body weight regulation. The majority of evidence comes from single-day studies, most of which have been conducted in adults. The purpose of this study was to investigate the effect of 3 test breakfasts-low-GI, low-GI with 10% added sucrose, and high-GI-on ad libitum lunch intake, appetite, and satiety and to compare these with baseline values when habitual breakfast was consumed. ⋯ These results suggest that low-GI foods eaten at breakfast have a significant impact on food intake at lunch. This is the first study to observe such an effect in a group of normal and overweight children and adds to the growing body of evidence that low-GI foods may have an important role in weight control and obesity management. The potentially confounding effect of differences in the macronutrient and dietary fiber content of the test breakfasts warrants additional study. In addition, the impact of GI on food intake and body weight regulation in the long term needs to be investigated.
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Randomized Controlled Trial Clinical Trial
Umbilical cord care in premature infants: the effect of two different cord-care regimens (salicylic sugar powder vs chlorhexidine) on cord separation time and other outcomes.
To evaluate the effect of 2 cord-care regimens (salicylic sugar powder vs chlorhexidine as a 4% detergent water solution) on cord separation time and other outcomes in preterm infants. ⋯ In neonatal intensive care units and neonatal special care units of developed countries, salicylic sugar powder can be used effectively and safely for UC care of preterm infants.