Clinical trial NCT04064684: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
Official title: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Keywords: Pediatric acute respiratory distress syndrome
PARDS
Budesonide
inhaled steroids
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-08-22
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Ventilator-free Days (VFD)
timeFrame: Between the time of enrollment and day 28 after enrollment
Secondary outcomes:
measure: Oxygenation Index (OI)
timeFrame: Day one to last day of last day of mechanical ventilation (up to 10 days)
measure: Oxygen Saturation Index (OSI)
timeFrame: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment
measure: Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)
timeFrame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
measure: Number of Days Participant Stayed in Hospital
timeFrame: from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
measure: TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 1
measure: TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 3
measure: TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 1
measure: IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 3
measure: IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 1
measure: IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 3
measure: IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 1
measure: MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 3
measure: MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 1
measure: MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: Day 3
measure: MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: Neutrophil Count
timeFrame: Day 1
measure: Neutrophil Count
timeFrame: Day 3
measure: Neutrophil Count
timeFrame: last day of treatment or last day of invasive mechanical ventilation( upto day 28)
measure: FEV1
timeFrame: 90 days since first day of treatment
measure: Forced Expiratory Volume at One Second FEV1/FVC
timeFrame: 90 days since first day of treatment
measure: Forced Vital Capacity (FVC)
timeFrame: 90 days since first day of treatment
measure: Forced Expiratory Flow FEF 25-75%
timeFrame: 90 days since first day of treatment
measure: Respiratory Resistance by Impulse Oscillometry (IOS)
timeFrame: 90 days since first day of treatment
measure: Respiratory Impedance by Impulse Oscillometry (IOS)
timeFrame: 90 days since first day of treatment
measure: Respiratory Reactance by Impulse Oscillometry (IOS)
timeFrame: 90 days since first day of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Alvaro J Coronado Munoz, MD
role: PRINCIPAL_INVESTIGATOR
References: