Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04064684
• Other study ID #: HSC-MS-19-0566
• Secondary ID: KL2TR003168
• Status: Terminated
• Phase: Phase 2
• Start date: February 4, 2020
• Est. completion date: March 30, 2020

Study information

• Verified date: June 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• 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.
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Ventilator-free Days (VFD)		Between the time of enrollment and day 28 after enrollment
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.	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.	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)		from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)
Secondary	Number of Days Participant Stayed in Hospital		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		Day 1
Secondary	TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 3
Secondary	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)
Secondary	Interleukin (IL) -6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 1
Secondary	IL-6 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 3
Secondary	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)
Secondary	IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 1
Secondary	IL-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 3
Secondary	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)
Secondary	MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 1
Secondary	MMP-8 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 3
Secondary	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)
Secondary	MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 1
Secondary	MMP-9 Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test		Day 3
Secondary	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)
Secondary	Neutrophil Count		Day 1
Secondary	Neutrophil Count		Day 3
Secondary	Neutrophil Count		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	90 days since first day of treatment
Secondary	Forced Expiratory Volume at One Second FEV1/FVC	Restrictive disease if <70%	90 days since first day of treatment
Secondary	Forced Vital Capacity (FVC)	<80% restrictive lung disease, L	90 days since first day of treatment
Secondary	Forced Expiratory Flow FEF 25-75%	Medium size bronchioles, normal 60-130%	90 days since first day of treatment
Secondary	Respiratory Resistance by Impulse Oscillometry (IOS)	Rrs 3-35 Hz	90 days since first day of treatment
Secondary	Respiratory Impedance by Impulse Oscillometry (IOS)	Zrs 3-35 Hz	90 days since first day of treatment
Secondary	Respiratory Reactance by Impulse Oscillometry (IOS)	Xrs 3-35 Hz	90 days since first day of treatment