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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003168 | U.S. NIH Grant/Contract | View source |
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Enrollment difficulties after the start of the COVID-19 pandemic.
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide administered by nebulizer | Experimental |
| |
| Placebo administered by nebulizer | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventilator-free Days (VFD) | Between the time of enrollment and day 28 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day one to last day of last day of mechanical ventilation (up to 10 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro J Coronado Munoz, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide Administered by Nebulizer | Budesonide: 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. Nebulizer: 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. |
| FG001 | Placebo Administered by Nebulizer | Placebo: 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. Nebulizer: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide Administered by Nebulizer | Budesonide: 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. Nebulizer: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Ventilator-free Days (VFD) | Posted | Number | days | Between the time of enrollment and day 28 after enrollment |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Budesonide Administered by Nebulizer | Budesonide: 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. Nebulizer: 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. |
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Enrollment difficulties after start of the COVID-19 pandemic leading to small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Jose Coronado Munoz, MD | The University of Texas Health Science Center at Houston | 713-500-5553 | Alvaro.J.CoronadoMunoz@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2019 | May 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2019 | May 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Placebo | Drug | 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. |
|
| Nebulizer | Device | 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. |
|
| 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. | 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) |
| TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 1 |
| TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 3 |
| 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 | Day 3 |
| 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) |
| IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 1 |
| IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 3 |
| 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 | Day 1 |
| MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 3 |
| 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 | Day 1 |
| MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Day 3 |
| 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) |
| Neutrophil Count | Day 1 |
| Neutrophil Count | Day 3 |
| Neutrophil Count | 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 | 90 days since first day of treatment |
| Forced Expiratory Volume at One Second FEV1/FVC | Restrictive disease if <70% | 90 days since first day of treatment |
| Forced Vital Capacity (FVC) | <80% restrictive lung disease, L | 90 days since first day of treatment |
| Forced Expiratory Flow FEF 25-75% | Medium size bronchioles, normal 60-130% | 90 days since first day of treatment |
| Respiratory Resistance by Impulse Oscillometry (IOS) | Rrs 3-35 Hz | 90 days since first day of treatment |
| Respiratory Impedance by Impulse Oscillometry (IOS) | Zrs 3-35 Hz | 90 days since first day of treatment |
| Respiratory Reactance by Impulse Oscillometry (IOS) | Xrs 3-35 Hz | 90 days since first day of treatment |
| BG001 | Placebo Administered by Nebulizer | Placebo: 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. Nebulizer: 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. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo: 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. Nebulizer: 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. |
|
|
| Secondary | 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. | For the participant in the budesonide arm, data for this outcome measure was not collected on days 9 and 10. | Posted | Mean | Standard Deviation | index | Day one to last day of last day of mechanical ventilation (up to 10 days) |
|
|
|
| Secondary | 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. | Data for this outcome measure were not collected for either participant. | Posted | Day one to last day of last day of mechanical ventilation up to 28 days since enrollment |
|
|
| Secondary | Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU) | Posted | Number | days | from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days) |
|
|
|
| Secondary | Number of Days Participant Stayed in Hospital | Posted | Number | days | from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days) |
|
|
|
| Secondary | TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | Neutrophil Count | Data for this outcome measure were not collected for any participant. | Posted | Day 1 |
|
|
| Secondary | Neutrophil Count | Data for this outcome measure were not collected for any participant. | Posted | Day 3 |
|
|
| Secondary | Neutrophil Count | Data for this outcome measure were not collected for any participant. | Posted | last day of treatment or last day of invasive mechanical ventilation( upto day 28) |
|
|
| Secondary | FEV1 | Forced expiration in 1st second, abnormal (obstructive)<80% L/second | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Forced Expiratory Volume at One Second FEV1/FVC | Restrictive disease if <70% | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Forced Vital Capacity (FVC) | <80% restrictive lung disease, L | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Forced Expiratory Flow FEF 25-75% | Medium size bronchioles, normal 60-130% | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Respiratory Resistance by Impulse Oscillometry (IOS) | Rrs 3-35 Hz | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Respiratory Impedance by Impulse Oscillometry (IOS) | Zrs 3-35 Hz | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| Secondary | Respiratory Reactance by Impulse Oscillometry (IOS) | Xrs 3-35 Hz | Data for this outcome measure were not collected for any participant. | Posted | 90 days since first day of treatment |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Administered by Nebulizer | Placebo: 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. Nebulizer: 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004864 | Equipment and Supplies |
| day 2 |
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| day 3 |
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| day 4 |
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| day 5 |
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| day 6 |
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| day 7 |
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| day 8 |
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| day 9 |
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| day 10 |
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