Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Ventilator-free Days (VFD)
研究概览
简要总结
The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
- •Patients requiring invasive mechanical ventilation.
- •Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal
排除标准
- •Patients with diffuse alveolar hemorrhage.
- •Patients terminally ill with limitation of care or in hospice care.
- •Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
- •Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.
研究组 & 干预措施
Budesonide administered by nebulizer
干预措施: Budesonide (Drug)
Budesonide administered by nebulizer
干预措施: Nebulizer (Device)
Placebo administered by nebulizer
干预措施: Placebo (Drug)
Placebo administered by nebulizer
干预措施: Nebulizer (Device)
结局指标
主要结局
Number of Ventilator-free Days (VFD)
时间窗: Between the time of enrollment and day 28 after enrollment
次要结局
- Neutrophil Count(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- Respiratory Impedance by Impulse Oscillometry (IOS)(90 days since first day of treatment)
- Oxygenation Index (OI)(Day one to last day of last day of mechanical ventilation (up to 10 days))
- TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(Day 1)
- IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- Oxygen Saturation Index (OSI)(Day one to last day of last day of mechanical ventilation up to 28 days since enrollment)
- Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)(from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days))
- Number of Days Participant Stayed in Hospital(from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days))
- Forced Vital Capacity (FVC)(90 days since first day of treatment)
- FEV1(90 days since first day of treatment)
- Forced Expiratory Flow FEF 25-75%(90 days since first day of treatment)
- IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test(last day of treatment or last day of invasive mechanical ventilation( upto day 28))
- Forced Expiratory Volume at One Second FEV1/FVC(90 days since first day of treatment)
- Respiratory Resistance by Impulse Oscillometry (IOS)(90 days since first day of treatment)
- Respiratory Reactance by Impulse Oscillometry (IOS)(90 days since first day of treatment)
研究者
Alvaro J Coronado Munoz
Assistant Professor
The University of Texas Health Science Center, Houston