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Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND: Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß?-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in children who attend the Emergency Department. METHODS/DESIGN: This is a randomized, non-inferiority, open-label clinical trial. After informed consent with or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The PRAM score, a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16?years, will be performed by a clinician blinded to treatment allocation. Secondary outcomes include relapse, hospital admission and requirement for further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to follow-up), we will be able to reject the null hypothesis - that the population means of the experimental and control groups are equal with a probability (power) of 0.9. The Type I error probability associated with this test (of the null hypothesis) is 0.05. DISCUSSION: This clinical trial may provide evidence that a shorter steroid course using dexamethasone can be used in the treatment of acute pediatric asthma, thus eliminating the issue of compliance to treatment. REGISTRATION: ISRCTN26944158 and EudraCT Number 2010-022001-18.

SUBMITTER: Cronin J

PROVIDER: S-EPMC3492215 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial.

Cronin John J Kennedy Una U McCoy Siobhan S An Fhailí Sinéad Nic SN Crispino-O'Connell Gloria G Hayden John J Wakai Abel A Walsh Sean S O'Sullivan Ronan R

Trials 20120821

<h4>Background</h4>Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for ß₂-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting corticosteroid with a half-life of 36 to ...[more]

PMID: 22909281

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Project description:BackgroundAsthma exacerbations are a serious public health concern due to high healthcare resource utilization, work/school productivity loss, impact on quality of life, and risk of mortality. The genetic basis of asthma exacerbations has been studied in several populations, but no prior study has performed a multi-ancestry meta-analysis of genome-wide association studies (meta-GWAS) for this trait. We aimed to identify common genetic loci associated with asthma exacerbations across diverse populations and to assess their functional role in regulating DNA methylation and gene expression.MethodsA meta-GWAS of asthma exacerbations in 4989 Europeans, 2181 Hispanics/Latinos, 1250 Singaporean Chinese, and 972 African Americans analyzed 9.6 million genetic variants. Suggestively associated variants (p ≤ 5 × 10-5 ) were assessed for replication in 36,477 European and 1078 non-European asthma patients. Functional effects on DNA methylation were assessed in 595 Hispanic/Latino and African American asthma patients and in publicly available databases. The effect on gene expression was evaluated in silico.ResultsOne hundred and twenty-six independent variants were suggestively associated with asthma exacerbations in the discovery phase. Two variants independently replicated: rs12091010 located at vascular cell adhesion molecule-1/exostosin like glycosyltransferase-2 (VCAM1/EXTL2) (discovery: odds ratio (ORT allele ) = 0.82, p = 9.05 × 10-6 and replication: ORT allele = 0.89, p = 5.35 × 10-3 ) and rs943126 from pantothenate kinase 1 (PANK1) (discovery: ORC allele = 0.85, p = 3.10 × 10-5 and replication: ORC allele = 0.89, p = 1.30 × 10-2 ). Both variants regulate gene expression of genes where they locate and DNA methylation levels of nearby genes in whole blood.ConclusionsThis multi-ancestry study revealed novel suggestive regulatory loci for asthma exacerbations located in genomic regions participating in inflammation and host defense.

Project description:ObjectivesThe emergency department (ED) represents a place and moment of opportunity to provide interventions to improve long-term asthma outcomes, but feasibility, effectiveness and mechanisms of impact are poorly understood. We aimed to review the existing literature on interventions that are delivered in the ED for adults and adolescents, targeting asthma outcomes beyond the ED, and to code the interventions according to theory used, and to understand the barriers and facilitators to their implementation.MethodsWe systematically searched seven electronic databases and research registers, and manually searched reference lists of included studies and relevant reviews. Both quantitative and qualitative studies that reported on interventions delivered in the ED which aimed to improve asthma outcomes beyond management of the acute exacerbation, for adolescents or adults were included. Methodological quality was assessed using the Mixed Methods Appraisal Tool and informed study interpretation. Theory was coded using the Theoretical Domains Framework. Findings were summarised by narrative synthesis.Results12 articles were included, representing 10 unique interventions, including educational and medication-based changes (6 randomised controlled trials and 4 non-randomised studies). Six trials reported statistically significant improvements in one or more outcome measures relating to long-term asthma control, including unscheduled healthcare, asthma control, asthma knowledge or quality of life. We identified limited use of theory in the intervention designs with only one intervention explicitly underpinned by theory. There was little reporting on facilitators or barriers, although brief interventions appeared more feasible.ConclusionThe results of this review suggest that ED-based asthma interventions may be capable of improving long-term outcomes. However, there was significant variation in the range of interventions, reported outcomes and duration of follow-up. Future interventions would benefit from using behaviour change theory, such as constructs from the Theoretical Domains Framework.Prospero registration numberCRD 42020223058.

Dataset Information

Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial.

Publications

Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial.

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