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Trial record 9 of 202 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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

Tracking Information
First Submitted Date  ICMJE August 16, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 22, 2019
Estimated Study Start Date  ICMJE September 4, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
Number of Ventilator-free days (VFD) [ Time Frame: Between the time of enrollment and day 28 after enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • 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
  • 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
  • Number of days participants stay in PICU [ Time Frame: from time of enrollment until participant is transferred,discharged or deceased(upto 28 days) ]
  • Number of days participants stay in hospital [ Time Frame: from time of enrollment until participant is transferred,discharged or deceased(upto 28 days) ]
  • TNF alpha levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  • TNF alpha levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  • 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) ]
  • Interleukin (IL) -6 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  • IL-6 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  • 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) ]
  • IL-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  • IL-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  • 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) ]
  • MMP-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  • MMP-8 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  • 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) ]
  • MMP-9 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 1 ]
  • MMP-9 levels as assessed by the enzyme-linked immunosorbent assay (ELISA) test [ Time Frame: Day 3 ]
  • 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) ]
  • Neutrophil count [ Time Frame: Day 1 ]
  • Neutrophil count [ Time Frame: Day 3 ]
  • Neutrophil count [ Time Frame: last day of treatment or last day of invasive mechanical ventilation( upto day 28) ]
  • FEV1 [ Time Frame: 90 days since first day of treatment ]
    Forced expiration in 1st second, abnormal (obstructive)<80% L/second
  • FEV1/FVC [ Time Frame: 90 days since first day of treatment ]
    Restictive disease if <70%
  • Forced vital capacity (FVC) [ Time Frame: 90 days since first day of treatment ]
    <80% restrictive lung disease, L
  • FEF 25-75% [ Time Frame: 90 days since first day of treatment ]
    Medium size bronchioles, normal 60-130%
  • Respiratory resistance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Rrs 3-35 Hz
  • Respiratory impedance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Zrs 3-35 Hz
  • Respiratory reactance by Impulse Oscillometry (IOS) [ Time Frame: 90 days since first day of treatment ]
    Xrs 3-35 Hz
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
Official Title  ICMJE Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome (PARDS), a Randomized Pilot Trial
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: treatment with Budesonide
    Intervention: Drug: Budesonide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alvaro J Coronado Munoz, MD 7137047921 Alvaro.J.CoronadoMunoz@uth.tmc.edu
Contact: Jon Meliones, MD 7137047921 Jon.Meliones@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04064684
Other Study ID Numbers  ICMJE HSC-MS-19-0566
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alvaro J Coronado Munoz, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alvaro J Coronado Munoz, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP