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

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: Budesonide; Drug: Placebo; Device: Nebulizer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04064684

KL2TR003168 (U.S. NIH Grant/Contract)

HSC-MS-19-0566

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: All

Ages: 30 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Budesonide administered by nebulizer

Experimental group

Treatment:

Device: Nebulizer

Drug: Budesonide

Placebo administered by nebulizer

Placebo Comparator group

Treatment:

Device: Nebulizer

Drug: Placebo