Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Registration Number
- NCT04064684
- Lead Sponsor
- The University of Texas Health Science Center, Houston
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Budesonide administered by nebulizer Nebulizer - Placebo administered by nebulizer Placebo - Placebo administered by nebulizer Nebulizer - Budesonide administered by nebulizer Budesonide -
- Primary Outcome Measures
Name Time Method Number of Ventilator-free Days (VFD) Between the time of enrollment and day 28 after enrollment
- Secondary Outcome Measures
Name Time Method 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 Zrs 3-35 Hz
Oxygenation Index (OI) Day one to last day of last day of mechanical ventilation (up to 10 days) Oxygenation index (OI) is calculated as (\[FiO2 x Mean Airway Pressure\] / PaO2). FiO2 stands for inspired fraction of oxygen, and PaO2 stands for pressure/arterial pressure of oxygen. An oxygenation index of 4-8 indicates mild ARDS, an oxygenation index of 8-16 indicates moderate ARDS, and an oxygenation index greater than 16 indicates severe ARDS.
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 5-7.5 mild ARDS, 7.5-12.3 moderate ARDS. \> 12.3 severe ARDS, formula FiO2\*Mean airway pressure/Saturation of O2
Oxygen saturation index (OI) is calculated as (\[FiO2 x Mean Airway Pressure\] / Saturation of oxygen). FiO2 stands for inspired fraction of oxygen. An oxygen saturation index of 5-7.5 indicates mild ARDS, an oxygen saturation index of 7.5-12.3 indicates moderate ARDS, and an oxygen saturation index greater than 12.3 indicates severe ARDS.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 \<80% restrictive lung disease, L
FEV1 90 days since first day of treatment Forced expiration in 1st second, abnormal (obstructive)\<80% L/second
Forced Expiratory Flow FEF 25-75% 90 days since first day of treatment Medium size bronchioles, normal 60-130%
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 Restrictive disease if \<70%
Respiratory Resistance by Impulse Oscillometry (IOS) 90 days since first day of treatment Rrs 3-35 Hz
Respiratory Reactance by Impulse Oscillometry (IOS) 90 days since first day of treatment Xrs 3-35 Hz
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States