NCT00798616撤回不适用
Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- length of hospitalization (actual and until meets "ready for discharge" criteria)
研究概览
简要总结
The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bronchiolitis
- •Respiratory Distress Assessment Index score of 4 or more
排除标准
- •prior prescription of bronchodilators or inhaled corticosteroids
- •birth at <36 weeks gestation
- •chronic cardiac disease
- •chronic pulmonary disease (including asthma)
- •immunodeficiency
- •non-topical steroid use in the prior week
- •parents that don't understand English
- •baseline systolic blood pressure >118 mmHg
- •home oxygen use
- •evidence of systemic fungal or varicella infection
- •bronchodilator use in the prior week
- •allergy to albuterol or corticosteroids
研究组 & 干预措施
Responders/Placebo
Placebo Comparator
Albuterol responders being given placebo
干预措施: placebo (Drug)
Responders/Steroids
Active Comparator
albuterol responders being given steroids
干预措施: prednisolone or methylprednisolone (Drug)
Non-responders/placebo
Placebo Comparator
non-albuterol responders being given placebo
干预措施: placebo (Drug)
non-responders/steroids
Active Comparator
non-albuterol responders being given steroids
干预措施: prednisolone or methylprednisolone (Drug)
结局指标
主要结局
length of hospitalization (actual and until meets "ready for discharge" criteria)
时间窗: variable, likely no more than 2 weeks
respiratory rate and respiratory distress score
时间窗: 4 hours
次要结局
- need for increased respiratory support (intubation, CPAP, BiPAP)(variable, likely up to 2 weeks)
- amount of oxygen used during hospitalization(variable, likely less than 2 weeks)
- total duration of symptoms(variable, likely no more than 3 weeks)
- need for unanticipated medical care after discharge(variable, likely no more than 3 weeks)
- tachycardia and/or hypertension during hospitalization(variable, likely no more than 2 weeks)
- number of doses of bronchodilators used during hospitalization(variable, likely no more than 2 weeks)
研究者
研究点 (1)
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