ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
NCT ID: NCT05388708
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
550 participants
OBSERVATIONAL
2021-02-04
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
An opportunity to address this question is provided by NHLBI-funded Prone and Oscillation Pediatric Clinical Trial (PROSpect) and the ECMO registry, Extracorporeal Life Support Organization (ELSO). PROSpect is an existing 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 1,000 children with severe PARDS. PROSpect manages subjects with a rigorous protocol that reserves ECMO for protocol failure. The ELSO Registry includes children receiving usual care ECMO, initiated at the discretion of the intensivist.
ASCEND harmonizes PROSpect and ELSO data collection and prospectively measures functional status and quality of life via surveys in an additional 550 children with severe PARDS from ELSO sites. ASCEND measures children's abilities and quality of life when the child was in their normal state of health (just prior to being hospitalized), at discharge from the pediatric intensive care unit, and at 1-month, 3-months, 6-months, and 12-months after discharge from the pediatric intensive care unit. After enrollment of the usual care ECMO (in ELSO) and PROSpect's protocolized therapies (from the PROSpect clinical trial) is complete, then ASCEND will match similarly critically ill children based on their propensity to receive usual care ECMO.
ASCEND combines real-world observational data (from ELSO) and a randomized clinical trial (from PROSpect) to address two specific aims.
Aim 1: The study will test the hypotheses that one year after children receive usual care ECMO for PARDS, there will be a decline in long-term functional status and health-related quality of life as well as an increase in the proportion of children receiving respiratory support.
Aim 2: The study will test the hypotheses that 90-day mortality, one-year functional status, and one-year health-related quality of life are not equivalent for children with usual care ECMO (in ELSO) and PROSpect's protocolized therapies.
Protocol change in November 2021:
Inclusion criteria: Extend the window between intubation and ECMO cannulation from 120 hours to 168 hours.
Exclusion criteria: Remove active air leak, critical airway, and facial surgery/trauma within the last 2 weeks.
Protocol change in October 2022:
Inclusion criteria:
1. Extended the age range from 14 days - 17 years to 14 days - 20 years of age.
2. Extended the window between intubation and ECMO cannulation from 168 hours to 240 hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
ECMO support
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
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.
PROSpect protocolized therapies
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ECMO support
ECMO prescribed by treating physicians for respiratory support in the setting of PARDS.
PROSpect protocolized therapies
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
14 Days
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ryan Barbaro
Associate Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ryan Barbaro, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Loma Linda University Children's Hospital
Loma Linda, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, United States
Nemours Children's Hospital, Florida
Orlando, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Comer Children's Hospital
Chicago, Illinois, United States
OSF Healthcare Children's Hospital of Illinois
Peoria, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa Health Care Stead Family Children's Hospital
Iowa City, Iowa, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Ochsner LSU Health Shreveport
Shreveport, Louisiana, United States
University of Maryland Children's Hospital
Baltimore, Maryland, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Children's Minnesota Hospital
Minneapolis, Minnesota, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Eugenio Litta Children's Hospital
Rochester, Minnesota, United States
Children's Mercy
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Children's Nebraska
Omaha, Nebraska, United States
UNM Children's Hospital
Albuquerque, New Mexico, United States
John R. Oishei Children's Hospital
Buffalo, New York, United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York, United States
NewYork-Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
NewYork-Presbyterian Komansky Children's Hospital
New York, New York, United States
Cohen Children's Medical Center
Queens, New York, United States
N.C. Children's Hospital
Chapel Hill, North Carolina, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist | Brenner Children's Hospital
Winston-Salem, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Children's Hospital OU Health
Oklahoma City, Oklahoma, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, United States
Penn State Health Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hasbro Children's
Providence, Rhode Island, United States
MUSC Shawn Jenkins Children's Hospital
Charleston, South Carolina, United States
Sanford Children's Hospital
Sious Falls, South Dakota, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
Medical City Children's Hospital
Dallas, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University Health Women's & Children's Hospital
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
UVA Children's Hospital
Charlottesville, Virginia, United States
Inova L.J. Murphy Children's Hospital
Falls Church, Virginia, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
UW Health American Family Children's Hospital
Madison, Wisconsin, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
The Royal Children's Hospital Melbourne
Melbourne, , Australia
Perth Children's Hospital
Perth, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
Stollery Children's Hospital
Edmonton, Alberta, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Pontificia Universidad
Santiago, , Chile
Fundacion Cardiovascular De Colombia
Floridablanca, , Colombia
Istituto Giannina Gaslini
Genoa, , Italy
Starship Children's Hospital
Grafton, Aukland, New Zealand
Hospital de Santa Maria
Lisbon, , Portugal
Children's Hospital and Vall d' Hebron Women's Hospital
Barcelona, , Spain
Sant Joan de Deu Barcelona Hospital
Barcelona, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
ECMO Centrum Karolinska
Stockholm, , Sweden
Royal Hospital for Children
Glasgow, , United Kingdom
Leicester Children's Hospital
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Evelina London Children's Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Southampton Children's Hospital
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Robert Richter, MD
Role: primary
Erin Kreml, MD
Role: primary
Matthew Malone, MD
Role: primary
Merrick Lopez, MD
Role: primary
Neeraj Srivastava, MD
Role: primary
Harry Kallas, MD
Role: primary
Mandeep Chadha, MD
Role: primary
Adam Schwarz, MD
Role: primary
Timothy Cornell, MD
Role: primary
Shan Ward, MD
Role: primary
John Kim, MD
Role: primary
Allison Cowl, MD
Role: primary
Josep Panisello, MD
Role: primary
Marisa Meyer, MD
Role: primary
Kourtney Guthrie, MD
Role: primary
Nicole Slone, MD
Role: primary
Timothy Maul, MD
Role: primary
Heather Viamonte, MD
Role: primary
Len Tanaka, MD
Role: primary
Bria Coates, MD
Role: primary
Karen Fauman, MD
Role: primary
Agnieszka Kulikowska, MD
Role: primary
Matt Friedman, MD
Role: primary
Kari Wellnitz, MD
Role: primary
Deanna Tzanetos, MD
Role: primary
Steve Conrad, MD
Role: primary
Mela Bembea, MD
Role: primary
Sally Vitali, MD
Role: primary
Kelli McDonough, MS
Role: primary
Mina Hafzala, MD
Role: primary
Elizabeth Rosner, MD
Role: primary
Mark Eikenberry, MD
Role: primary
Jeffrey Weatherhead, MD
Role: primary
Asdis Wagner, MD
Role: primary
Erik Madsen, MD
Role: primary
Ahmed Said, MD
Role: primary
Santosh Kaipa, MD
Role: primary
Senan Hadid, MD
Role: primary
Ryan Breuer, MD
Role: primary
Arun Chopra, MD
Role: primary
Eva Cheung, MD
Role: primary
Umesh Joashi, MD
Role: primary
Todd Sweberg, MD
Role: primary
Katherine Clement, MD
Role: primary
Palen Mallory, MD
Role: primary
Alan Woodruff, MD
Role: primary
Patricia Raimer, MD
Role: primary
Ranjit Chima, MD
Role: primary
Karen Lidsky, MD
Role: primary
Joshua Frazier, MD
Role: primary
Christine Allen, MD
Role: primary
Amit Mehta, MD
Role: primary
Elizabeth Kerris, MD
Role: primary
Adam Himebaugh, MD
Role: primary
Nahmah Kim-Campbell, MD
Role: primary
Ranna Rozenfeld, MD
Role: primary
Elise Zivick, MD
Role: primary
Jody Huber, MD
Role: primary
Hitesh Sandhu, MD
Role: primary
Kevin Johnson, MD
Role: primary
Samantha Dallefeld, MD
Role: primary
JJ Fanning, MD
Role: primary
Archana Dhar, MD
Role: primary
Sonia Labarinas, MD
Role: primary
Andrea Ontaneda, MD
Role: primary
Veronica Armijo-Garcia, MD
Role: primary
Anna Hubbard, MD
Role: primary
Gary Fang, MD
Role: primary
Jeremy Lamkin, MD
Role: primary
Thomas Brogan, MD
Role: primary
Charlie Bergstrom, MD
Role: primary
Adam Szadkowski, MD
Role: primary
Warwick Butt
Role: primary
Simon Erickson
Role: primary
Adrian Mattke
Role: primary
Nithesh Singhal
Role: primary
Laurance Lequier
Role: primary
Anne Marie Guerguerian
Role: primary
Javier Kattan, MD
Role: primary
Leonardo Salazar
Role: primary
Andrea Moscatelli
Role: primary
John Beca
Role: primary
Francisco Abecasis
Role: primary
Joan Balcells Ramirez
Role: primary
Susana Segura Matute
Role: primary
Laura Butragueno Laiseca
Role: primary
Lars Broman
Role: primary
Mark Davidson
Role: primary
Claire Westrope
Role: primary
Marie Horan
Role: primary
Jonathan Lillie
Role: primary
Justin Wang
Role: primary
Timothy Thiruchelvam
Role: primary
Judit Llevadias
Role: primary
Vanessa Stanley
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pollack 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.
Varni 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.
Varni 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.
Pollack 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.
Keim 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.
Combes 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00173031
Identifier Type: -
Identifier Source: org_study_id