CTRI/2025/09/094073尚未招募3 期
Effect of Methylprednisolone in Paediatric Acute Respiratory Distress Syndrome in addition to standard care on length of hospital stay
ABVIMS and Dr RML hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
After obtaining Institutional Ethics Committee approval and written informed consent from the patients, 28 patients per group will be enrolled for the study. Screening will be done using a predesigned proforma for elegibiltiy of the child for inclusion in the study.
If the child is elegible for study, consent will be obtained and the child will be randomly assigned to one of the study intervention, study intervention will be started and data will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group: 1month -18years
- •Diagnosis of ARDS based on PALICC 2 consensus guidelines
- •Mechanically ventilated for less than 72 hrs.
排除标准
- •Patients receiving steroids already
- •Terminally ill or on hospise care
- •Immunosuppressed
- •Extensive burns
- •Adrenal insufficiency
- •Invasive fungal infection
- •Chronic liver disease
- •Gastrointestinal bleed in past 1 month.
结局指标
主要结局
Length of hospital stay
时间窗: date of discharge from hospital-date of randomisation
次要结局
- Ventilator free days(2. Length of PICU stay)
研究者
Dr Sudha Chandelia
ABVIMS and Dr RML hospital, delhi
研究点 (1)
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