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Impact of ECMO on neurodevelopment in children with ARDS

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

Observational University of Michigan · NCT05388708

This study looks at how using ECMO for children with severe breathing problems affects their long-term health and development compared to those who wait to use ECMO until it's really needed.

Quick facts

Study typeObservational
Enrollment550 (estimated)
Ages14 Days to 20 Years
SexAll
SponsorUniversity of Michigan Academic / other
Locations99 sites (Birmingham, Alabama and 98 other locations)
Trial IDNCT05388708 on ClinicalTrials.gov

What this trial studies

The ASCEND project investigates the long-term outcomes and quality of life in children who receive extracorporeal membrane oxygenation (ECMO) for pediatric acute respiratory distress syndrome (PARDS). It aims to compare two groups of children: those managed with a mechanical ventilation protocol that delays ECMO until necessary and those receiving ECMO as per usual care. By partnering with families, the study seeks to gather data on children's abilities and health after leaving the pediatric intensive care unit. This observational study utilizes existing clinical trial data and registry information to enhance understanding of ECMO's impact on survival and quality of life.

Who should consider this trial

Good fit: Ideal candidates are children diagnosed with moderate to severe pediatric ARDS who require ECMO support within 10 days of intubation.

Not a fit: Patients with perinatal lung disease, congenital heart defects, or other specific respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights that improve the management and outcomes of children with severe ARDS requiring ECMO.

How similar studies have performed: While there have been studies on ECMO in pediatric populations, this specific approach comparing initiation strategies is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Time between intubation and ECMO cannulation is less than 240 hours (10 days)
* ECMO support type is respiratory (VV or VA cannulation)
* Chest radiograph with bilateral lung disease
* Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation:

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

Exclusion Criteria:

* Previously enrolled in PROSpect
* Perinatal related lung disease
* Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
* Respiratory failure caused by cardiac failure or fluid overload
* Cyanotic congenital heart disease
* Cardiomyopathy
* Primary pulmonary hypertension (PAH)
* Unilateral lung disease
* Intubated for status asthmaticus
* Obstructive airway disease
* Bronchiolitis obliterans
* Post hematopoietic stem cell transplant
* Post lung transplant
* Home ventilator dependent
* Neuromuscular respiratory failure
* Head trauma: (managed with hyperventilation)
* Intracranial bleeding
* Unstable spine, femur or pelvic fractures
* Acute abdominal process/open abdomen
* Family/medical team have decided to not provide full support
* Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.
* Known pregnancy

Where this trial is running

Birmingham, Alabama and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Respiratory Distress SyndromeExtracorporeal Membrane OxygenationARDSECMOExtracorporeal Life SupportECLSPediatricQuality of Life
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.