Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Budesonide; Placebo; Nebulizer
Intervention description: 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.
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 2.0
Sex: All
Minimum age: 30 Days
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric acute respiratory distress syndrome; PARDS; Budesonide; inhaled steroids

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.