Trial Outcomes & Findings for Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome (NCT NCT04113434)
NCT ID: NCT04113434
Last Updated: 2026-04-20
Results Overview
28 day all cause mortality.
Recruitment status
COMPLETED
Target enrollment
513 participants
Primary outcome timeframe
28 days
Results posted on
2026-04-20
Participant Flow
Recruitment Period: 1/7/2020 - 5/8/2024 Sites: 16 (PICU)
Participant milestones
| Measure |
Pediatric ARDS Observational Cohort
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
Overall Study
STARTED
|
513
|
|
Overall Study
COMPLETED
|
500
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Pediatric ARDS Observational Cohort
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Not able to collect samples within the enrollment time window.
|
10
|
Baseline Characteristics
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Baseline characteristics by cohort
| Measure |
Pediatric ARDS Observational Cohort
n=513 Participants
Subjects meeting study eligibility criteria admitted to the PICU of one of the 16 collaborating sites.
|
|---|---|
|
Age, Categorical
<=18 years
|
513 Participants
n=129 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=129 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
109 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
390 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
326 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: 28 days28 day all cause mortality.
Outcome measures
| Measure |
Pediatric ARDS Observational Cohort
n=500 Participants
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
28 Day Mortality in Pediatric ARDS.
|
44 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of ARDS onsetStratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.
Outcome measures
| Measure |
Pediatric ARDS Observational Cohort
n=500 Participants
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
Presence of Two or More Endotypes in Pediatric ARDS.
|
70 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours of ARDS onset.Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.
Outcome measures
| Measure |
Pediatric ARDS Observational Cohort
n=500 Participants
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
Occurrence of de Novo Sub-phenotypes in Pediatric ARDS Using Biomarkers and Whole Genome Transcriptomics of Peripheral Blood.
|
70 Participants
|
SECONDARY outcome
Timeframe: 28 dayscomposite endpoint of days alive and free of mechanical ventilation by day 28.
Outcome measures
| Measure |
Pediatric ARDS Observational Cohort
n=500 Participants
Subjects meeting study eligibility criteria admitted to the PICU of one of the collaborating sites.
|
|---|---|
|
Ventilator-free Days at 28 Days.
|
20 days
Interval 10.0 to 24.0
|
Adverse Events
Pediatric ARDS Observational Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 67 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place