ECMO Support for Acute Respiratory Distress Syndrome in Children

(ASCEND Trial)

Recruiting at 97 trial locations

Overseen By Kelli McDonough, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Congenital heart disease, Cardiomyopathy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 10 days

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ECMO, a life support machine that takes over lung function, affects children's recovery after experiencing pediatric acute respiratory distress syndrome (PARDS). Researchers aim to understand ECMO's impact on children's abilities and quality of life one year after leaving intensive care. The trial compares two treatment approaches: one group uses ECMO only when other methods fail, while the other follows usual care practices. Eligible children have experienced sudden breathing failure due to PARDS and have been intubated for less than ten days. As a Phase 2 trial, this research measures ECMO's effectiveness in an initial, smaller group of children, contributing to important findings in pediatric care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ECMO support and PROSpect protocolized therapies are safe for children with PARDS?

Research has shown that extracorporeal membrane oxygenation (ECMO) is a well-known treatment for serious lung problems, such as pediatric acute respiratory distress syndrome (PARDS). Several studies have examined its safety. One study found no major difference in death rates between children on ECMO and those treated with other methods, suggesting similar safety levels. Another study showed that 35% of ECMO patients died within 60 days, compared to 46% in a group not using ECMO, indicating ECMO might reduce the risk of death. However, ECMO can cause serious issues like heart problems.

For the PROSpect protocolized therapies, which use different breathing machine techniques, specific safety data is limited. These therapies focus on mechanical ventilation methods and only use ECMO if needed. The trial is part of a larger study examining different ways to treat severe PARDS.

Overall, ECMO and PROSpect therapies have different levels of safety evidence. ECMO is generally well-tolerated but carries some risks, while PROSpect protocols aim to improve current treatments with ECMO as a backup option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASCEND trial because it explores advanced strategies for managing pediatric acute respiratory distress syndrome (PARDS), focusing on ECMO support and the PROSpect protocolized therapies. Unlike standard care, which often relies on conventional mechanical ventilation, the ECMO support offers a more direct way to oxygenate the blood outside the body, potentially benefiting patients with severe cases. Meanwhile, the PROSpect protocol involves a highly structured approach, including prone positioning and high-frequency oscillatory ventilation, which could optimize care and outcomes for children with severe respiratory distress. This trial aims to understand how these innovative methods might improve neurodevelopmental outcomes, providing hope for more effective treatments for young patients with PARDS.

What evidence suggests that this trial's treatments could be effective for pediatric acute respiratory distress syndrome?

In this trial, participants will be divided into two cohorts. The Usual Care ECMO Cohort will involve ECMO, a machine that assists with breathing. Previous studies have shown consistent results, with more than 50% of children with severe breathing problems surviving after hospital discharge. Research also indicates that ECMO can reduce death rates in children compared to adults with similar breathing issues.

The PROSpect protocolized therapies cohort will explore early findings that suggest specific breathing techniques and body positions, such as lying on the back versus the stomach, might benefit children with severe breathing problems. This approach aims to use ECMO only when other methods fail. Together, these treatments offer promising options for managing serious breathing issues in children. ^{2 6 7 8 9}

Who Is on the Research Team?

Ryan Barbaro, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

ECMO support type is respiratory (VV or VA cannulation)

Chest radiograph with bilateral lung disease

One OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ECMO support or mechanical ventilation as per protocol for pediatric acute respiratory distress syndrome (PARDS)

Up to 10 days

Continuous monitoring during hospitalization

Follow-up

Participants are monitored for functional status and quality of life at multiple intervals after PICU discharge

12 months

Assessments at 1, 3, 6, and 12 months post-discharge

Long-term Monitoring

Ongoing assessment of health-related quality of life and functional status

Beyond 12 months

What Are the Treatments Tested in This Trial?

Interventions

• ECMO support
• PROSpect protocolized therapies

How Is the Trial Designed?

Group I: Usual care ECMO Cohort Experimental Treatment 1 Intervention

The cohort will be comprised of 550 patients, aged 14 days to 20 years, who go on extracorporeal membrane oxygenation (ECMO) support due to pediatric acute respiratory distress syndrome (PARDS) at physician discretion. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \< 16 and one OSI \> 10 (at least 4 hours apart) Subjects must be on mechanical ventilation for less than 240 hours (10 days) prior to cannulation. These measures must be after endotracheal intubation and before ECMO start. Chest radiograph prior to ECMO must show bilateral lung disease. Subjects cannulated on ECMO for no more than 96 hours prior to gaining consent.

Group II: PROSpect protocolized therapies cohort Experimental Treatment 1 Intervention

The cohort will be comprised of 1000 patients, aged 14 days to 20 years, who are endotracheally intubated for PARDS. Patients with qualifying PARDS must have one oxygenation index (OI) ≥ 16 or two OIs 12 ≥ to \< 16 (at least 4 hours apart) or two oxygenation saturation indexes (OSIs) ≥ 10 (at least 4 hours apart) or one OI 12 ≥ to \< 16 and one OSI \> 10 (at least 4 hours apart). These measures must be after endotracheal intubation. Chest radiograph must show bilateral lung disease. Patient must be enrolled in a clinical trial Prone and Oscillation Pediatric Clinical Trial (PROSpect) NCT01515787 which is distinct from ASCEND. PROSpect is a response adaptive randomized clinical trial, testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in children with severe PARDS. PROSpect manages severe PARDS subjects using a rigorous protocol that reserves ECMO for protocol failure.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6828785/

Extra-corporeal membrane oxygenation in paediatric acute ... Despite the increasing complexity of children supported by ECMO for ARDS, outcomes have remained consistent with survival to hospital discharge greater than 50% ...

2. journals.lww.com journals.lww.com/ccejournal/fulltext/2024/09000/outcomes_of_extracorporeal_membrane_oxygenation_in.6.aspx

Outcomes of Extracorporeal Membrane Oxygenation in ... Our study showed ECMO intervention in children with ARDS after trauma had a lower mortality rate compared with ECMO intervention in ARDS in adult trauma ...

3. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.201802-0221LE

American Journal of Respiratory and Critical Care Medicine Their main finding was that the mortality rate of ECMO-supported children was not significantly different from that of non–ECMO-supported children. There were ...

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1556642/full

Efficacy and safety of extracorporeal membrane ... This study aimed to evaluate the efficacy and safety of extracorporeal membrane oxygenation combined with continuous renal replacement therapy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11390049/

Outcomes of Extracorporeal Membrane Oxygenation in ... Our study showed ECMO intervention in children with ARDS after trauma had a lower mortality rate compared with ECMO intervention in ARDS in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39254656/

Outcomes of Extracorporeal Membrane Oxygenation in ... No difference in mortality was observed in injured children who suffered from the ARDS and were placed on ECMO when compared with patients ...

7. journals.lww.com journals.lww.com/ccejournal/fulltext/2021/05000/outcomes_of_extracorporeal_membrane_oxygenation_in.17.aspx

Outcomes of Extracorporeal Membrane Oxygenation in ... Our study did show a significant difference in the mortality outcome in patients who were placed on ECMO versus the CMV (35.6% vs 14.4%; p = 0.001). The reason ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1800385

Extracorporeal Membrane Oxygenation for Severe Acute ... At 60 days, 44 of 124 patients (35%) in the ECMO group and 57 of 125 (46%) in the control group had died (relative risk, 0.76; 95% confidence ...

9. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.14814

Abstract 14814: Predictors and Outcomes of Extracorporeal ... Patients placed on venoarterial-ECMO had higher odds of cardiogenic shock (aOR 13.4, CI 3.95 to 46, P<0.001), cardiac arrest (aOR 3.5, CI 1.45 ...