ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
ASCEND
2 other identifiers
observational
550
11 countries
99
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Longer than P75 for all trials
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2021
CompletedFirst Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 24, 2025
December 1, 2025
6.7 years
May 18, 2022
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in functional status
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 assessment method to quantify functional status. The FSS includes 6 domains: mental status, sensory functioning, communication, motor function, feeding, and respiratory. Scores for each domain range from 1 (normal) to 5 (very severe dysfunction); total scores range from 6 to 30 with higher scores reflecting worse functioning.
baseline and 1 year after pediatric intensive care unit discharge
Change in health-related quality of life
This primary natural history outcome is measured among usual care ECMO patients. This outcome is the change in the health-related quality of life as measured at baseline and 12 months after PICU discharge. The instrument is the age-appropriate Version 4.0 Pediatric Quality of Life Inventory (PedsQL 4.0) generic core scales for acute illness. PedsQL 4.0 Generic Core Scales and Infant Scales - Acute Version are parent proxy-report scales. The scales ranges from 0 to 100, with higher scores indicating fewer problems. PedsQL 4.0 Generic Core Scales is a 23-item scale with 4 domains: physical functioning, emotional functioning, social functioning, and school functioning. The PedsQL Infant Scales consist of 36-45 questions, depending on age, with 5 domains: physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning.
baseline and 1 year after pediatric intensive care unit discharge
The proportion of children with a new morbidity
This primary natural history outcome is measured among usual care ECMO patients. A new morbidity is defined as a change in the functional status scale score instrument by 3 or more, as previously described. This outcome will report the proportion of children who acquire a new morbidity as measured at baseline and 12 months after PICU discharge. The Functional Status Scale (FSS) is a valid and reliable assessment method to quantify functional status. The FSS includes 6 domains: mental status, sensory functioning, communication, motor function, feeding, and respiratory. Scores for each domain range from 1 (normal) to 5 (very severe dysfunction); total scores range from 6 to 30 with higher scores reflecting worse functioning.
baseline and 1 year after pediatric intensive care unit discharge
All-cause mortality at hospital discharge or 90-days
This primary comparative short-term outcome is measured among both usual care ECMO and Prone and Oscillation Pediatric Clinical Trial (PROSpect) protocolized therapy groups. The outcome compares the 90-day mortality for matched children in the two groups. The endpoint is 90 days after the day of illness on which patients from the two cohorts are matched or hospital discharge.
90 days after the day of illness on which patients from the two cohorts are matched
Comparative change in one-year functional status
This primary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. The outcome compares the change in the functional status as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the functional status scale score. The Functional Status Scale (FSS) is a valid and reliable assessment method to quantify functional status. The FSS includes 6 domains: mental status, sensory functioning, communication, motor function, feeding, and respiratory. Scores for each domain range from 1 (normal) to 5 (very severe dysfunction); total scores range from 6 to 30 with higher scores reflecting worse functioning.
baseline and 1 year after pediatric intensive care unit discharge
Comparative change in one-year health-related quality of life
This primary comparative long-term outcome is measured among both usual care ECMO and PROSpect protocolized therapy groups. The outcome compares the change in the health-related quality of life as measured at baseline and 12 months after PICU discharge between matched children in the two groups. The instrument is the change in the age-appropriate PedsQL 4.0 generic core scales for acute illness. PedsQL 4.0 Generic Core Scales and Infant Scales - Acute Version are parent proxy-report scales. The scales ranges from 0 to 100, with higher scores indicating fewer problems. PedsQL 4.0 Generic Core Scales is a 23-item scale with 4 domains: physical functioning, emotional functioning, social functioning, and school functioning. The PedsQL Infant Scales consist of 36-45 questions, depending on age, with 5 domains: physical functioning, physical symptoms, emotional functioning, social functioning, and cognitive functioning.
baseline and 1 year after pediatric intensive care unit discharge
Secondary Outcomes (16)
Change in pediatric overall performance category
baseline and 1 year after pediatric intensive care unit discharge
Change in pediatric cerebral performance category
baseline and 1 year after pediatric intensive care unit discharge
Change in breathing support
baseline and 1 year after pediatric intensive care unit discharge
Change in the psychosocial component of health-related quality of life
baseline and 1 year after pediatric intensive care unit discharge
Change in the physical component of health-related quality of life
baseline and 1 year after pediatric intensive care unit discharge
- +11 more secondary outcomes
Study Arms (2)
Usual care ECMO Cohort
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.
PROSpect protocolized therapies cohort
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.
Interventions
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
PROSpect is testing the impact of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV) on clinical outcomes in 1,000 children with severe PARDS. PROSpect manages severe PARDS subjects using a protocol that reserves ECMO for protocol failure. The CMV group targets an exhaled tidal volume of 5-7mL/kg of ideal body weight and a peak inspiratory pressure \<28 cm of H2O. The positive end expiratory pressure (PEEP) and FiO2 are titrated by a PEEP-FiO2 titration grid. The HFOV group titrates the mean airway pressure to target a FiO2 \< 0.5 and a goal hemoglobin oxygen saturation of 88-92%. The frequency is titrated between 8-12 Hz and amplitude from 60-90 to achieve a goal pH of 7.15-7.30. Ventilation protocols are implemented until 28 days or extubation. Children randomized to the prone positioning will remain prone for at least 16 consecutive hours per day. Children randomized to supine positioning group remain supine.
Eligibility Criteria
The study population comes from pediatric patients hospitalized for respiratory distress requiring intubation and ECMO. Namely, children are eligible if they have moderate to severe PARDS, meet inclusion criteria and do not have the exclusion criteria listed below under exclusion criteria. Children in ELSO's usual care ECMO cohort also cannot be enrolled in PROSpect, and they must have respiratory ECMO initiated at an ELSO site within 10 days of intubation.
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
Children's of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Loma Linda University Children's Hospital
Loma Linda, California, 92354, United States
UCLA Mattel Children's Hospital
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93636, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304, United States
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, 94158, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06511, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803, United States
UF Health Shands Children's Hospital
Gainesville, Florida, 32608, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Nemours Children's Hospital, Florida
Orlando, Florida, 32827, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, 96826, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Comer Children's Hospital
Chicago, Illinois, 60637, United States
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, 61637, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Health Care Stead Family Children's Hospital
Iowa City, Iowa, 52242, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Ochsner LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
University of Maryland Children's Hospital
Baltimore, Maryland, 21201, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Children's Minnesota Hospital
Minneapolis, Minnesota, 55404, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Mayo Eugenio Litta Children's Hospital
Rochester, Minnesota, 55902, United States
Children's Mercy
Kansas City, Missouri, 64108, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Nebraska
Omaha, Nebraska, 68114, United States
UNM Children's Hospital
Albuquerque, New Mexico, 87106, United States
John R. Oishei Children's Hospital
Buffalo, New York, 14203, United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York, 10016, United States
NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032, United States
NewYork-Presbyterian Komansky Children's Hospital
New York, New York, 10065, United States
Cohen Children's Medical Center
Queens, New York, 11040, United States
N.C. Children's Hospital
Chapel Hill, North Carolina, 27514, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705, United States
Atrium Health Wake Forest Baptist | Brenner Children's Hospital
Winston-Salem, North Carolina, 27157, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43215, United States
Oklahoma Children's Hospital OU Health
Oklahoma City, Oklahoma, 73104, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Penn State Health Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Hasbro Children's
Providence, Rhode Island, 02903, United States
MUSC Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425, United States
Sanford Children's Hospital
Sious Falls, South Dakota, 57105, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Medical City Children's Hospital
Dallas, Texas, 75230, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University Health Women's & Children's Hospital
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
UVA Children's Hospital
Charlottesville, Virginia, 22903, United States
Inova L.J. Murphy Children's Hospital
Falls Church, Virginia, 22042, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
UW Health American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Royal Children's Hospital Melbourne
Melbourne, VIC 3052, Australia
Perth Children's Hospital
Perth, WA 6009, Australia
Queensland Children's Hospital
South Brisbane, QLD 4101, Australia
The Children's Hospital at Westmead
Westmead, NSW 2145,, Australia
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8, Canada
Pontificia Universidad
Santiago, 8331150, Chile
Fundacion Cardiovascular De Colombia
Floridablanca, 681004, Colombia
Istituto Giannina Gaslini
Genoa, 16147, Italy
Starship Children's Hospital
Grafton, Aukland, 1023, New Zealand
Hospital de Santa Maria
Lisbon, 1649-028, Portugal
Children's Hospital and Vall d' Hebron Women's Hospital
Barcelona, 08035, Spain
Sant Joan de Deu Barcelona Hospital
Barcelona, 08950, Spain
Hospital Gregorio Maranon
Madrid, 28007, Spain
ECMO Centrum Karolinska
Stockholm, 17176, Sweden
Royal Hospital for Children
Glasgow, G51 4FT, United Kingdom
Leicester Children's Hospital
Leicester, LE3 9QP, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AP, United Kingdom
Evelina London Children's Hospital
London, SE1 7EH, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Great Ormond Street Hospital for Children
London, WC1N 3JH, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE77DN, United Kingdom
Southampton Children's Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (7)
Fiser DH. Assessing the outcome of pediatric intensive care. J Pediatr. 1992 Jul;121(1):68-74. doi: 10.1016/s0022-3476(05)82544-2.
PMID: 1625096BACKGROUNDPollack MM, Holubkov R, Glass P, Dean JM, Meert KL, Zimmerman J, Anand KJ, Carcillo J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Functional Status Scale: new pediatric outcome measure. Pediatrics. 2009 Jul;124(1):e18-28. doi: 10.1542/peds.2008-1987.
PMID: 19564265BACKGROUNDVarni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PMID: 11468499BACKGROUNDVarni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
PMID: 10024117BACKGROUNDPollack MM, Holubkov R, Funai T, Berger JT, Clark AE, Meert K, Berg RA, Carcillo J, Wessel DL, Moler F, Dalton H, Newth CJ, Shanley T, Harrison RE, Doctor A, Jenkins TL, Tamburro R, Dean JM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment. Crit Care Med. 2015 Aug;43(8):1699-709. doi: 10.1097/CCM.0000000000001081.
PMID: 25985385BACKGROUNDKeim G, Watson RS, Thomas NJ, Yehya N. New Morbidity and Discharge Disposition of Pediatric Acute Respiratory Distress Syndrome Survivors. Crit Care Med. 2018 Nov;46(11):1731-1738. doi: 10.1097/CCM.0000000000003341.
PMID: 30024428BACKGROUNDCombes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.
PMID: 29791822BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Barbaro, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 24, 2022
Study Start
February 4, 2021
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Two years after study analysis is complete.
- Access Criteria
- ASCEND investigators will compose the ASCEND steering committee lead by PI Barbaro. Members include Ryan Barbaro, Theodore Iwashyna, Martha Curley, Carol Hodgson, Seth Warschausky and Ben Hansen. The steering committee will be responsible for developing publication procedures and resolving authorship issues.
It is the National Institutes of Health (NIH) policy that the results and accomplishments of the activities that it funds should be made available to the public (see https://grants.nih.gov/policy/sharing.htm). After the study is completed, the de-identified, archived data will be transmitted to and stored at the Biologic Specimen and Data Repository Information Coordination Center (BioLINCC), for use by other researchers including those outside of the study. Permission to transmit data to the BioLINCC will be included in the informed consent.