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Completed

NCT Number: NCT03539783

Identifying PARDS Endotypes

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Respiratory Tract Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All potential participants must:

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

ARDS patients must:

  • Have acute changes in chest x-ray (CXR)
  • Have a known or suspected insult within the prior 7 days that is consistent with ARDS
  • Have an oxygenation index (OI) of 4 or greater or and oxygen-sat index (OSI) of 5 or greater
  • OI = mean airway pressure X fraction inspired oxygen (FiO2) / arterial oxygen partial pressure (PaO2)
  • OSI = mean airway pressure X FiO2 / oxyhemoglobin saturation (SpO2) with sat <= 97%.

Exclusion criteria

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

Treatment and study plan

Respiratory epithelial cell brushing

Diagnostic Test

At specified time points, nasal brushings will be performed to obtain RNA.

Primary outcomes

  1. Identification of PARDS Endotypes

    Time frame: 6 years

    Use of unbiased cluster analysis of gene expression to identify subtypes in PARDS

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Society of Critical Care Medicine

Registry information

Official study title

Identification of Pediatric Acute Respiratory Distress Syndrome Subtypes by Bronchial and Nasal Epithelial Transcriptomics

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 29, 2018
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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