INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
研究概览
简要总结
The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 2 and 18 years.
- •History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.
- •Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure [PRAM] score ≥8).
排除标准
- •Patients with suspected or confirmed foreign body aspiration.
- •Patients with concurrent croup.
- •Presence of comorbidities (cardiovascular, neurological, malignancy, chronic kidney or lung disease).
- •Patients with pneumonia.
- •Patients with air leaks (pneumothorax, pneumomediastinum).
- •Patients requiring immediate Intensive Care Unit (ICU) admission.
- •Systemic steroid use within the last 8 weeks.
- •Failure to obtain informed consent.
结局指标
主要结局
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
时间窗: At 4 hours after the initiation of treatment in the emergency department.
The PRAM score is a validated clinical scoring system used to assess asthma severity in children. It evaluates clinical signs including suprasternal retractions, scalene muscle contraction, air entry, wheezing, and O2 saturation. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
PRAM Score on the 2nd Day Post-Discharge
时间窗: 2 days after discharge from the hospital
The PRAM score will be calculated to assess the patient's respiratory status during the follow-up visit. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
次要结局
- Total Number of Salbutamol Doses(Up to 14 days post-discharge.)
- Hospitalization Rate(Up to 4 hours post-treatment initiation in the emergency department.)
- Length of Hospital Stay(From hospital admission to hospital discharge (an expected average of 2 to 5 days))
- Rate of Re-presentation to the Hospital(Within 14 days post-discharge)
- Re-hospitalization Rate(Within 14 days post-discharge)
- Incidence of Adverse Events(Up to 14 days post-discharge)
研究者
Esen Besli
Assoc. Prof. Dr.
Istanbul Medeniyet University