Betamethasone dose for croup in young children (1–3 years of age) has been shown to be safe and well tolerated by most children (1,3). Because the incidence and severity of asthma is greater in the first year of life, and it is thought that the etiology of asthma and chronic obstructive pulmonary disease (COPD) in children is multifactorial and mediated by multiple environmental factors, it has been suggested that the use of corticosteroids and allergic rhinitis medications could serve as complementary risk-reducing strategies. Recent evidence suggests a dose-dependent relationship between the use of corticosteroids and croup in children. For example, a recent systematic review published in 2007 concluded that low to moderate levels of systemic corticosteroids are associated with increased risk of croup and, in some situations, increased severity of croup (5). In contrast, there is only a weak correlation between the use of corticosteroids and severity croup (4). However, the use of corticosteroids as part the treatment of acute or chronic asthma and allergic rhinitis is becoming more common buy phentermine with prescription in the United States. During last decade, the use of corticosteroids in children has increased significantly among US children, from 3.8% in 1988–1990 to 9.4% 1998. However, these trends differ markedly between African, Hispanic, and white children. As reported by the National Ambulatory Medical Care Survey, the use of corticosteroids for asthma is growing fastest among Hispanic children and of black white race were most likely to use these medications for asthma (3). A study on the effects of systemic corticosteroids in young children published 2003 found that corticosteroid doses of 50 to 200 mg/day were well tolerated in children with acute or chronic asthma and allergic rhinitis. There was no increase in the incidence of asthma, acute otitis media, or symptoms of allergic rhinitis after a dose increase of 50 or more mg in a single dose (6). It was suggested that a reduction in the frequency of asthma attacks by the use of systemic corticosteroids was achieved through the increase in serum corticosteroid levels. Furthermore, the use of such medications may decrease the risk of emergence asthma complications, such as exacerbations or asthma-related allergy (5). In addition, the effect on incidence of rhinitis and symptoms allergic was more than the control group in this study, suggesting that the beneficial effects of systemic corticosteroids might be more pronounced in children with asthma and allergic rhinitis. However, this study was limited by the small sample size and lack of a control group children who were not exposed to systemic corticosteroids. The purpose of this study was to determine the effect of systemic corticosteroids on the incidence of croup in young children. This study will be a randomized controlled trial (RCT) and will be powered to detect a 5% difference between groups, with a power of 80% and 90% to detect a 5% difference in the incidence of croup after 10 weeks treatment in the croup-free group and after 15 weeks of treatment in the croup-exposed group. It will use a 2-part study design. First, children will be randomly assigned to receive either the treatment or placebo for 10 weeks. A similar design was used in a previous RCT conducted 1997 and 1998 (7), where 5 children received systemic corticosteroids and 13 children received placebo. A 5% difference was detected between the 2 groups for incidence of croup. In the present study, croup-free group will be compared with the croup-exposed group in order to obtain a larger sample size. The children will be followed up at the end of trial. primary outcome will be the incidence of croup in croup-free group and the croup-exposed group. MATERIALS AND METHODS Study design and setting The present study will be a randomized, controlled trial of the effect systemic corticosteroids (cortisol, prednisone, or a combination) on the incidence of croup among young children. It will be conducted at the Johns Hopkins Children's Center of the University Maryland, Baltimore, Maryland (http://www.children.umd.edu/). The Johns Hopkins Children's Center is a pediatric hospital located on the campus of Johns Hopkins University School Medicine. The study is a 2-part, double-blind, placebo-controlled, crossover trial. The first part of study is a trial 10 weeks in which both groups receive their usual daily prednisone dose of 1–2 mg/kg. During this trial, the croup-free group and croup-exposed will be randomly assigned to receive a corticosteroid (3, 25 mg/m)

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