Identifying PARDS Endotypes

NCT03539783 | Completed

• 1 other identifier: CIN_PARDSEndo_001
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Adult

Keywords

Endotype; Pediatric Acute Respiratory Distress Syndrome; Gene Expression; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• Identification of PARDS Endotypes

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

  6 years

Secondary Outcomes (3)

• Lung Recovery Gene Expression Profile

  6 years

• Correlation of Nasal and Bronchial Gene Expression

  6 years

• Correlation of Endotypes with Lung Cell-specific Biomarkers

  6 years

Study Arms (2)

PARDS

Children \<18 years of age with PARDS and expected duration of hospitalization seven days or greater.

Diagnostic Test: Respiratory epithelial cell brushing

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

Interventions

Respiratory epithelial cell brushing DIAGNOSTIC_TEST

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

Control; PARDS

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Society of Critical Care Medicine: collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Williams JG, Jones RL, Yunger TL, Lahni PM, Yehya N, Varisco BM. Comparison of 16 Pediatric Acute Respiratory Distress Syndrome-Associated Plasma Biomarkers With Changing Lung Injury Severity. Pediatr Crit Care Med. 2024 Jan 1;25(1):e31-e40. doi: 10.1097/PCC.0000000000003311. Epub 2023 Jun 29.

  PMID: 37382480 RESULT

• Williams JG, Joshi R, Haslam D, Yehya N, Jones RL, Paranjpe A, Pujato M, Roskin KM, Lahni PM, Wong HR, Varisco BM. Multi-omic characterization of pediatric ARDS via nasal brushings. Respir Res. 2022 Jul 9;23(1):181. doi: 10.1186/s12931-022-02098-3.

  PMID: 35804409 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

RNA and DNA from brushing specimens. Serum.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Stephen M Standage, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: April 1, 2018
• Primary Completion: August 11, 2022
• Study Completion: September 5, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)