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

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ClinicalTrials.gov Identifier: NCT04064684
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Alvaro J Coronado Munoz, The University of Texas Health Science Center, Houston

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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: Budesonide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
Estimated Study Start Date : September 4, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
Experimental: treatment with Budesonide Drug: Budesonide
Enrolled patients will be treated with Pulmicort Repsules®, Budesonide inhalation suspension [57], 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 Comparator: Placebo Drug: 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.




Primary Outcome Measures :
  1. Number of Ventilator-free days (VFD) [ Time Frame: Between the time of enrollment and day 28 after enrollment ]

Secondary Outcome Measures :
  1. Oxygenation index (OI) [ Time Frame: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment ]
    4-8 mild ARDS, 8-16 moderate ARDS. > 16 severe ARDS, formula FiO2*Mean airway pressure/PaO2

  2. Oxygen saturation index (OSI) [ Time Frame: Day one to last day of last day of mechanical ventilation up to 28 days since enrollment ]
    5-7.5 mild ARDS, 7.5-12.3 moderate ARDS. > 12.3 severe ARDS, formula FiO2*Mean airway pressure/Saturation of O2

  3. Number of days participants stay in PICU [ Time Frame: from time of enrollment until participant is transferred,discharged or deceased(upto 28 days) ]
  4. Number of days participants stay in hospital [ Time Frame: from time of enrollment until participant is transferred,discharged or deceased(upto 28 days) ]
  5. TNF alpha levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  6. TNF alpha levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  7. TNF alpha levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  8. Interleukin (IL) -6 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  9. IL-6 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  10. IL-6 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  11. IL-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  12. IL-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  13. IL-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  14. MMP-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  15. MMP-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  16. MMP-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  17. MMP-9 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  18. MMP-9 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  19. MMP-9 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  20. Neutrophil count [ Time Frame: Day 1 ]
  21. Neutrophil count [ Time Frame: Day 3 ]
  22. Neutrophil count [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  23. FEV1 [ Time Frame: 90 days since first day of treatment ]
    Forced expiration in 1st second, abnormal (obstructive)<80% L/second

  24. FEV1/FVC [ Time Frame: 90 days since first day of treatment ]
    Restictive disease if <70%

  25. Forced vital capacity (FVC) [ Time Frame: 90 days since first day of treatment ]
    <80% restrictive lung disease, L

  26. FEF 25-75% [ Time Frame: 90 days since first day of treatment ]
    Medium size bronchioles, normal 60-130%

  27. Respiratory resistance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Rrs 3-35 Hz

  28. Respiratory impedance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Zrs 3-35 Hz

  29. Respiratory reactance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Xrs 3-35 Hz



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064684


Contacts
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Contact: Alvaro J Coronado Munoz, MD 7137047921 Alvaro.J.CoronadoMunoz@uth.tmc.edu
Contact: Jon Meliones, MD 7137047921 Jon.Meliones@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Alvaro J Coronado Munoz, MD    713-704-7921    Alvaro.J.CoronadoMunoz@uth.tmc.edu   
Contact: Jon Meliones, MD    7137047921    Jon.Meliones@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Alvaro J Coronado Munoz, MD The University of Texas Health Science Center, Houston

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Responsible Party: Alvaro J Coronado Munoz, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04064684     History of Changes
Other Study ID Numbers: HSC-MS-19-0566
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alvaro J Coronado Munoz, The University of Texas Health Science Center, Houston:
Pediatric acute respiratory distress syndrome
PARDS
Budesonide
inhaled steroids
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists