CompletedNot Applicable

Establishment of a Early Risk Model of ECMO in Children With ARDS

China95 participantsStarted 2018-01-01

Plain-language summary

The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment

Who can participate

Age range

28 Days – 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: * Acute onset; within 7 days of clinical insult * Chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease * Edema not fully explained by fluid overload or cardiac failure * May present as new acute lung disease in setting of chronic lung disease and/or heart disease * OI≥16 * Viral etiology is clear Exclusion Criteria: * Perinatal lung disease * Large intracranial bleed with mass effect or need for neurosurgical intervention * Hypoxic cardiac arrest without adequate CPR * Irreversible underlying cardiac or lung pathology (and not a transplant candidate) * Pulmonary hypertension and chronic lung disease * Chronic multiorgan dysfunction * Incurable malignancy * Allogenic bone marrow recipients with pulmonary infiltrates * Hepatic or renal failure * Pertussis infection in infants * Fungal pneumonia * Immunodeficiency

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

Survival rate

Timeframe: 28 days after hospital discharge

Trial details

NCT IDNCT04710173

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More ARDS trials