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NCT05388708 · ClinicalTrials.gov registry record
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
A clinical trial of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation, sponsored by University of Michigan.
- Recruiting
- Registry status
- 550
- Enrollment target
- 20
- Study locations
NCT05388708: Recruiting study of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation, sponsored by University of Michigan.
NCT05388708 is a study of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 550 participants, above the 350-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388708, a study of Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- 550 participants
- Enrollment target
- 20
- Study locations
Study Summary
ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.
Primary Outcome
This primary natural history outcome is measured among usual care extracorporeal membrane oxygenation (ECMO) patients. This outcome is the change in functional status as measured at baseline and 12 months after pediatric intensive care unit (PICU) discharge. The instrument is the functional status scale score. The baseline measure will be made within 96 hours of ECMO initiation and reflect patient's status in the week prior to ECMO. The Functional Status Scale (FSS) is a valid and reliable asse
Conditions Studied
Interventions
- DEVICE ECMO support
- OTHER PROSpect protocolized therapies
Study Locations (20)
California
- Loma Linda University Children's Hospital - Loma Linda
- UCLA Mattel Children's Hospital - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford - Palo Alto
- UCSF Benioff Children's Hospital - San Francisco - San Francisco
Florida
- UF Health Shands Children's Hospital - Gainesville
- Nicklaus Children's Hospital - Miami
- Orlando Health Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital, Florida - Orlando
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale New Haven Children's Hospital - New Haven
Alabama
- Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours Children's Hospital, Delaware - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2021-02-04 |
| Est. Completion | 2027-09-30 |
What NCT05388708 shows while recruiting
NCT05388708 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 350-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (57% higher).
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which ECMO support is the first listed.
NCT05388708 names 20 study sites across 10 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05388708 about?
NCT05388708 is a clinical study titled "ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)". ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do...
What is the current status of trial NCT05388708?
This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2021-02-04. Estimated completion is 2027-09-30.
What conditions does trial NCT05388708 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation.
What interventions are being tested in trial NCT05388708?
The interventions under investigation include: ECMO support (DEVICE), PROSpect protocolized therapies (OTHER).
Who is sponsoring clinical trial NCT05388708?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388708 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Respiratory Distress Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05388708's enrollment target sits among peer trials
550 7th of 31 higher than 25 of 31 other Acute Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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