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Identifying PARDS Endotypes

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ClinicalTrials.gov Identifier: NCT03539783
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Pediatric acute respiratory distress syndrome (PARDS) is a severe and diffuse lung injury that is a common cause of admission and mortality in the pediatric intensive care unit (PICU). PARDS can be secondary to many different causes, and there are few therapies that have been shown beneficial in PARDS. This study seeks to identify important PARDS subtypes using gene expression profiling of bronchial epithelial cells from control and PARDS subjects.

Condition or disease Intervention/treatment
Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Diagnostic Test: Respiratory epithelial cell brushing

Detailed Description:
Enrolled subjects will have nasal brushings collected at days 1, 3, 7, and 14 of intubation with collection of serum at these same time points. Brushing RNA will be processed by mRNA-Seq for gene expression analysis and compared to previously published serum biomarkers (interleukin-8, advanced glycosylation end-product specific receptor, and angiopoietin-2) to assess correlation and ability to discriminate PARDS endotypes. Changes in gene expression over time will be assessed to define a PARDS recovery gene expression signature, and correlation between bronchial and nasal gene expression will be determined.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of Pediatric Acute Respiratory Distress Syndrome Subtypes by Bronchial and Nasal Epithelial Transcriptomics
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025


Group/Cohort Intervention/treatment
PARDS
Children <18 years of age with PARDS and expected duration of hospitalization seven days or greater.
Diagnostic Test: Respiratory epithelial cell brushing
At specified time points, nasal brushings will be performed to obtain RNA.

Control
Children <18 years of age without PARDS or other lung disease and expected duration of hospitalization 7 days or greater.
Diagnostic Test: Respiratory epithelial cell brushing
At specified time points, nasal brushings will be performed to obtain RNA.




Primary Outcome Measures :
  1. Identification of PARDS Endotypes [ Time Frame: 6 years ]
    Use of unbiased cluster analysis of gene expression to identify subtypes in PARDS


Secondary Outcome Measures :
  1. Lung Recovery Gene Expression Profile [ Time Frame: 6 years ]
    Determination of pathways and processes that differentiate PARDS recovery from non-recovery as assessed by improvement in oxygenation.

  2. Correlation of Nasal and Bronchial Gene Expression [ Time Frame: 6 years ]
    Similarity analysis of bronchial and nasal gene expression in subjects undergoing bronchoscopy to determine whether nasal can be used as a surrogate for bronchial

  3. Correlation of Endotypes with Lung Cell-specific Biomarkers [ Time Frame: 6 years ]
    Matching PARDS endotypes with published markers of hyperinflammatory, microvascular-injury predominant, and distal lung epithelial cell-predominant injury


Biospecimen Retention:   Samples With DNA
RNA and DNA from brushing specimens. Serum.


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Control subjects will be patients admitted to the PICU for non-lung injury related conditions.

PARDS subjects will be intubated patients with PARDS in the PICU.

Criteria

Inclusion Criteria:

All potential participants must:

  1. Be aged zero to 18 years (both control and ARDS, not age matched)
  2. Be admitted to the PICU with expected duration of hospitalization 7 days or greater.

ARDS patients must:

  1. Have acute changes in chest x-ray (CXR)
  2. Have a known or suspected insult within the prior 7 days that is consistent with ARDS
  3. Have an oxygenation index (OI) of 4 or greater or and oxygen-sat index (OSI) of 5 or greater

    1. OI = mean airway pressure X fraction inspired oxygen (FiO2) / arterial oxygen partial pressure (PaO2)
    2. OSI = mean airway pressure X FiO2 / oxyhemoglobin saturation (SpO2) with sat <= 97%.

Exclusion Criteria:

  1. Have a baseline oxygen requirement of 2 liters of oxygen or greater at home
  2. Have disruption of the nasal passages
  3. Have a history of excessive bleeding or known bleeding disorders
  4. Be at high risk of bleeding
  5. Have a do not resuscitate (DNR) or Limited Resuscitation Order

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): NCT03539783


Contacts
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Contact: Rhonda Jones, RN 513-636-9749 rhonda.jones@cchmc.org
Contact: Toni Yunger 513-636-5572 toni.yunger@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Rhonda Jones, RN    513-636-9749    rhonda.jones@cchmc.org   
Contact: Toni Yunger    5136365572    toni.yunger@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03539783     History of Changes
Other Study ID Numbers: CIN_PARDSEndo_001
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study info will be shared with interested investigators on a case by case basis. Microarray data will be posted on an archive such as GeoDatasets but we are unclear how correlative clinical and serum biomarker data would be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Endotype
Pediatric Acute Respiratory Distress Syndrome
Gene Expression
Transcriptomics
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury