Intravenous Magnesium Sulphate Versus Placebo in clinical recovery time in moderate to severe Bronchiolitis :A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is to assess clinical recovery in children aged 2 months to 2 years diagnosed with moderate to severe bronchiolitis. Clinical recovery is defined as achieving a Bronchiolitis Severity Score (BSS) of less than 3. The observations will be conducted for a period of up to 7 days from the time of enrollment or until clinical recovery is achieved, whichever occurs earlier. The primary measure will be the time (in days) taken to reach clinical recovery.
研究概览
简要总结
This double-blind randomized controlled trial investigated the efficacy of intravenous magnesium sulphate compared to placebo in reducing clinical recovery time in children diagnosed with moderate to severe bronchiolitis. The study aimed to evaluate whether magnesium sulphate, known for its potential bronchodilatory and anti-inflammatory effects, could lead to faster recovery in affected pediatric patients. Participants were randomly assigned to receive either magnesium 40mg/kg iv stat dose or a placebo, and their clinical outcomes were closely monitored. Data will be analyzed at the end of study to obtain primary and secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •All previously healthy children belonging to age group of 2 months to 2 years diagnosed as moderate to severe bronchiolitis according to modified wangs severity scoring system , presenting to AIIMS Raipur.
排除标准
- •1, All children requiring mechanical ventilation at presentation or having hemodynamic instability , requiring vasoactive support.
- •2 History of bronchodilator, corticosteroids use in same episode, those with previous history of wheezing , hemodynamically significant heart disease , immunodeficiency , cystic fibrosis , bronchopulmonary dysplasia .
- •3Faily history of cardiovascular disorder (arrythmias), neuromuscular weakness , renal pathology will be excluded from the study 4 During hospital stay if child was diagnosed with pneumonia (viral/bacterial) would be eliminated from thesis.
结局指标
主要结局
The primary outcome of this study is to assess clinical recovery in children aged 2 months to 2 years diagnosed with moderate to severe bronchiolitis. Clinical recovery is defined as achieving a Bronchiolitis Severity Score (BSS) of less than 3. The observations will be conducted for a period of up to 7 days from the time of enrollment or until clinical recovery is achieved, whichever occurs earlier. The primary measure will be the time (in days) taken to reach clinical recovery.
时间窗: The primary outcome of this study is to assess clinical recovery in children aged 2 months to 2 years diagnosed with moderate to severe bronchiolitis. Clinical recovery is defined as achieving a Bronchiolitis Severity Score (BSS) of less than 3. The BSS will be recorded at 0hrs,2hrs,4hrs,6hrs,9hrs,12hrs,18hrs,24hrs ,thrice daily till clinical recovery acheived in both the magnesium sulphate group and the standard of care group.
次要结局
- The secondary outcomes of this study include the proportion (in percentage) of children requiring oxygen support during hospitalization, and the rate of mechanical ventilation among the study participants. The median duration (in days) of hospital stay will be recorded to assess the impact of the intervention on length of hospitalization. The study will also monitor for adverse effects of magnesium sulphate, including decreased urine output and hypotension, throughout the treatment period.(1- 14 days)
研究者
Dr Prachi Parmanand Nikose
All India Institute of Medical Science , Raipur