Respiratory Distress SyndromeNCT03539783
Identifying PARDS Endotypes
An observational study of Respiratory Distress Syndrome and Respiratory Distress Syndrome, Adult, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Distress Syndrome, Respiratory Distress Syndrome, Adult
- What is being tested?
- Respiratory epithelial cell brushing
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2018to 5 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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%.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Identification of Pediatric Acute Respiratory Distress Syndrome Subtypes by Bronchial and Nasal Epithelial Transcriptomics
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.
Read the 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.
- Being tested
- Respiratory epithelial cell brushing
- Keywords
- Endotype, Pediatric Acute Respiratory Distress Syndrome, Gene Expression, Transcriptomics
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory epithelial cell brushingDiagnostic test
At specified time points, nasal brushings will be performed to obtain RNA.
| Study group | Role | What they receive |
|---|---|---|
| PARDS | Children <18 years of age with PARDS and expected duration of hospitalization seven days or greater. Receives: 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. Receives: Diagnostic Test: Respiratory epithelial cell brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of PARDS Endotypes
Use of unbiased cluster analysis of gene expression to identify subtypes in PARDS
Measured: 6 years
Secondary outcomes (3)
Lung Recovery Gene Expression Profile
Determination of pathways and processes that differentiate PARDS recovery from non-recovery as assessed by improvement in oxygenation.
Measured: 6 years
Correlation of Nasal and Bronchial Gene Expression
Similarity analysis of bronchial and nasal gene expression in subjects undergoing bronchoscopy to determine whether nasal can be used as a surrogate for bronchial
Measured: 6 years
Correlation of Endotypes with Lung Cell-specific Biomarkers
Matching PARDS endotypes with published markers of hyperinflammatory, microvascular-injury predominant, and distal lung epithelial cell-predominant injury
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Apr 2018
- Primary completion11 Aug 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Sponsor
- Investigators
- Stephen M Standage, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539783
- Sponsor's protocol ID
- CIN_PARDSEndo_001
- Status last verified
- Mar 2024
- First submitted
- 16 May 2018
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37382480Williams 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.
PubMed 35804409
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Pediatric Acute Respiratory Distress Syndrome Subtypes by Bronchial and Nasal Epithelial Transcriptomics
- ClinicalTrials.gov ID
- NCT03539783
- Acronym / sponsor ID
- CIN_PARDSEndo_001
- Keywords
- Endotype, Pediatric Acute Respiratory Distress Syndrome, Gene Expression, Transcriptomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARDS | – | Diagnostic Test: Respiratory epithelial cell brushingChildren <18 years of age with PARDS and expected duration of hospitalization seven days or greater. |
| Control | – | Diagnostic Test: Respiratory epithelial cell brushingChildren <18 years of age without PARDS or other lung disease and expected duration of hospitalization 7 days or greater. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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.
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory epithelial cell brushingAt specified time points, nasal brushings will be performed to obtain RNA. | Diagnostic test | Control, PARDS |
Primary outcome
Identification of PARDS Endotypes
Time frame: 6 years
Use of unbiased cluster analysis of gene expression to identify subtypes in PARDS
3 secondary outcomes
Lung Recovery Gene Expression Profile
Time frame: 6 years
Correlation of Nasal and Bronchial Gene Expression
Time frame: 6 years
Correlation of Endotypes with Lung Cell-specific Biomarkers
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 37382480Williams 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.
- Results publication: PubMed 35804409Williams 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Respiratory Distress Syndrome
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Standage, MD principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Respiratory Distress Syndrome, Adult, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of PARDS Endotypes (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.