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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Ventilator-free Days (VFD)
Time frame: Between the time of enrollment and day 28 after enrollment
Oxygenation Index (OI)
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.
Time frame: Day one to last day of last day of mechanical ventilation (up to 10 days)
Oxygen Saturation Index (OSI)
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.
Time frame: 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)
Time frame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
Number of Days Participant Stayed in Hospital
Time frame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: 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
Time frame: Day 1
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 1
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: 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
Time frame: Day 1
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: 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
Time frame: Day 1
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: Day 3
MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
Neutrophil Count
Time frame: Day 1
Neutrophil Count
Time frame: Day 3
Neutrophil Count
Time frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
FEV1
Forced expiration in 1st second, abnormal (obstructive)\<80% L/second
Time frame: 90 days since first day of treatment
Forced Expiratory Volume at One Second FEV1/FVC
Restrictive disease if \<70%
Time frame: 90 days since first day of treatment
Forced Vital Capacity (FVC)
\<80% restrictive lung disease, L
Time frame: 90 days since first day of treatment
Forced Expiratory Flow FEF 25-75%
Medium size bronchioles, normal 60-130%
Time frame: 90 days since first day of treatment
Respiratory Resistance by Impulse Oscillometry (IOS)
Rrs 3-35 Hz
Time frame: 90 days since first day of treatment
Respiratory Impedance by Impulse Oscillometry (IOS)
Zrs 3-35 Hz
Time frame: 90 days since first day of treatment
Respiratory Reactance by Impulse Oscillometry (IOS)
Xrs 3-35 Hz
Time frame: 90 days since first day of treatment
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