RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-04
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Days to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Time between intubation and ECMO cannulation is less than 240 hours (10 days)
  2. * ECMO support type is respiratory (VV or VA cannulation)
  3. * Chest radiograph with bilateral lung disease
  4. * Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation:
  1. * Previously enrolled in PROSpect
  2. * Perinatal related lung disease
  3. * Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
  4. * Respiratory failure caused by cardiac failure or fluid overload
  5. * Cyanotic congenital heart disease
  6. * Cardiomyopathy
  7. * Primary pulmonary hypertension (PAH)
  8. * Unilateral lung disease
  9. * Intubated for status asthmaticus
  10. * Obstructive airway disease
  11. * Bronchiolitis obliterans
  12. * Post hematopoietic stem cell transplant
  13. * Post lung transplant
  14. * Home ventilator dependent
  15. * Neuromuscular respiratory failure
  16. * Head trauma: (managed with hyperventilation)
  17. * Intracranial bleeding
  18. * Unstable spine, femur or pelvic fractures
  19. * Acute abdominal process/open abdomen
  20. * Family/medical team have decided to not provide full support
  21. * Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols.
  22. * Known pregnancy

Contacts and Locations

Study Contact

Kelli McDonough, MS
CONTACT
734-232-1998
kellimcd@umich.edu

Principal Investigator

Ryan Barbaro, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Ryan Barbaro, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-04
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-02-04
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • ARDS
  • Acute Respiratory Distress Syndrome
  • Extracorporeal Membrane Oxygenation
  • ECMO
  • Extracorporeal Life Support
  • ECLS
  • Pediatric
  • Quality of Life
  • Functional Status

Additional Relevant MeSH Terms

  • Acute Respiratory Distress Syndrome
  • Extracorporeal Membrane Oxygenation