Oral Prednisolone Dosing in Children Hospitalized With Asthma
調査の概要
詳細な説明
Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these guidelines vary widely with respect to dose, frequency, method of delivery, and duration of therapy. In actual practice, there is also considerable variation among clinicians in terms of corticosteroid dosing in children hospitalized with asthma exacerbations. At the Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of 4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30 mg/dose). Systematic reviews of the literature have called for a clinical trial to evaluate the effect of different doses of corticosteroids in treating pediatric asthma patients hospitalized with exacerbations.
This study will use a randomized, double-blind, controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children. Children being hospitalized for asthma exacerbations from the CHOP emergency department (ED) will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose (1.0 mg/kg (max 30 mg) every 6 hours), or the lower dose (1.0 mg/kg (max 30 mg) every 12 hours and placebo doses at 6 hour intervals in between) for the first 48 hours of hospitalization. Once 48 hours has past, all patients still hospitalized will receive 1.0 mg/kg (max 30 mg) every 12 hours for the duration of hospitalization. Approximately 156 patients with 78 in each arm of the study will be enrolled. This study should be completed in six to eight months. A non-inferiority study design will be used. The primary outcome will be duration of hospitalization, as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department (ED) until the discharge dose of albuterol is administered. Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written, time spent in each severity level of the asthma care pathway, degree and rate of improvement in forced expiratory volume in one second (FEV1), improvement in peak expiratory flows (PEF), improvement in asthma symptom scores, and rate of relapse after discharge.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- The Children's Hospital of Philadelphia
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Physician-diagnosed asthma with at least two previous visits to ED or primary care provider for asthma care
- Clinical decision by ED attending physician to admit to Acute Care Unit (ACU) after standardized initial ED treatment
Exclusion Criteria:
- Clinical decision to begin continuous intravenous beta-agonist infusion
- Clinical decision to begin intravenous methylprednisolone therapy
- Clinical decision to admit to the Pediatric Intensive Care Unit
- Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
- Any contraindication to corticosteroid administration
- Any systemic corticosteroid treatment within two weeks of presenting to the ED
- Potential subjects will be excluded if informed consent is not obtained
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:1
High dose prednisolone
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4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
他の名前:
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実験的:2
Lower dose prednisolone alternating with placebo
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2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
時間枠:Median time from loading dose to home dose of albuterol
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Median time from loading dose to home dose of albuterol
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order
時間枠:Mean time from writing admit order until discharge order
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Mean time from writing admit order until discharge order
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Time Spent in Each Severity Level of the Asthma Care Pathway
時間枠:Time spent in each severity level of pathway
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Time spent in each severity level of pathway
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The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups
時間枠:Every 4 hours during hospitalization
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Every 4 hours during hospitalization
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Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups
時間枠:Every 4 hours during hospitalization
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Every 4 hours during hospitalization
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Rate of Relapse Between Treatment Groups
時間枠:2 weeks after hospitalization
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2 weeks after hospitalization
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協力者と研究者
捜査官
- 主任研究者:Joseph J Zorc, MD、Children's Hospital of Philadelphia
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2005-9-4377
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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