CompletedNot Applicable

Identifying PARDS Endotypes

United States76 participantsStarted 2018-04-01

Plain-language 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.

Who can participate

Age range

1 Month – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identification of PARDS Endotypes

Timeframe: 6 years

Trial details

NCT IDNCT03539783

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-11

View on ClinicalTrials.gov More Respiratory Distress Syndrome trials