Major trial seeks to end debate on ventilator strategies for kids
NCT ID NCT03896763
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two breathing support strategies—prone positioning and high-frequency ventilation—against standard care in 600 children with severe acute respiratory distress syndrome. The goal is to see which approach helps children spend more days off a ventilator within 28 days. The trial is active but no longer recruiting, and results may guide future pediatric intensive care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prone positioning and high-frequency oscillatory ventilation
- What this could lead to
- If it works, this could establish a better standard of care for children with severe lung failure, reducing time on breathing machines.
- What could go wrong
- This is a late-stage trial but still compares existing techniques; the benefit may be small or not apply to all children. No new drug is being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2019
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 weeks to 20 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: Intubated and mechanically ventilated with high moderate-severe PARDS for \<48 hours per PALICC guidelines (chest imaging consistent with acute pulmonary parenchymal disease and OI ≥12 or OSI ≥10). We require two blood gases meeting moderate-severe PARDS criteria (separated by at least 4 ± 2 hours during which time the clinical team is actively working to recruit lung volume and optimize the patient's hemodynamic status per PALICC guidelines; specifically, incremental and decremental PEEP changes to optimize lung volume). A second blood gas is not required for OI ≥16. Exclusion criteria: * Perinatal related lung disease * Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis * Respiratory failure explained by cardiac failure or fluid overload * Cyanotic heart disease * Cardiomyopathy * Unilateral lung disease * Primary pulmonary hypertension * Intubated for status asthmaticus * Obstructive airway disease (e.g., Severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 \<0.30 and/or evidence of increased resistance visible on the flow - time scalar and/or presence of intrinsic PEEP) * Active air leak * Bronchiolitis obliterans * Post hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at time of meeting inclusion criteria; spending more than four days in the PICU prior to intubation; supported on or with immediate plans for renal replacement therapies; with two or more allogeneic transplants; who relapsed after the transplant; or with diffuse alveolar hemorrhage * Post lung transplant * Home ventilator dependent with baseline Oxygen Saturation Index (OSI) \>6 * Neuromuscular respiratory failure * Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass) * Facial surgery or trauma in previous 2 weeks * Head trauma (managed with hyperventilation) * Intracranial bleeding * Unstable spine, femur or pelvic fractures * Open abdomen * Currently receiving more than 6 consecutive hours of either prone positioning or HFOV * Supported on ECMO during the current admission * Family/medical team not providing full support (patient treatment considered futile) * Previously enrolled in current study * Enrolled in any other interventional clinical trial not approved for co-enrollment * Known pregnancy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute respiratory distress syndrome in children are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
American Family Children's Hospital, University of Wisconsin
Madison, Wisconsin, 53792, United States
-
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
-
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
-
Bambino Gesu Children's Hospital (Area Rossa Unit)
Rome, Italy, Italy
-
Banner Health
Phoenix, Arizona, 85006, United States
-
Birmingham Children's Hospital
Birmingham, UK, United Kingdom
-
Bloomberg Children's Center, Johns Hopkins University
Baltimore, Maryland, 21287, United States
-
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
-
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T1C5, Canada
-
Children's Health Dallas
Dallas, Texas, 75235, United States
-
Children's Hospital Orange County
Orange, California, 92868, United States
-
Children's Hospital and Medical Center
Omaha, Nebraska, 68198, United States
-
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
-
Children's Hospital at Westmead
Sydney, Australia
-
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014, United States
-
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
-
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
-
Children's of Alabama
Birmingham, Alabama, 35233, United States
-
Chonnam National University Hospital
Gwangju, South Korea
-
Cohen Children's Medical Center
Queens, New York, 11040, United States
-
Duke Children's Hospital
Durham, North Carolina, 27710, United States
-
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand
-
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
-
Hadassah Medical Center
Jerusalem, Israel
-
Hospital SEPACO
São Paulo, Brazil
-
Hospital de Pediatría J. P. Garrahan. SAMIC
Buenos Aires, Buenos Aires F.D., C1245AAM, Argentina
-
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
-
Instituto Giannina Gasilini
Genova, Italy
-
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813, United States
-
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
-
LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
-
Medical City Dallas
Dallas, Texas, 75230, United States
-
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
-
Meyer Children's Hospital
Florence, Italy, Italy
-
Münster University Hospital
Münster, Germany
-
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
-
Penn State Children's Hospital
Hershey, Pennsylvania, 17033, United States
-
Perth Children's Hospital
Perth, Western Australia, 6840, Australia
-
Rainbow Children's Hospital
Hyderabad, India
-
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202, United States
-
Sabara Hospital Infantil
São Paulo, Brazil, Brazil
-
Shaikh Khalifa Medical City
Abu Dhabi, United Arab Emirates
-
Stanford Children's Health
Palo Alto, California, 94304, United States
-
Texas Children's Hospital
Houston, Texas, 77030, United States
-
UH Rainbow Babies & Children
Cleveland, Ohio, 44106, United States
-
University Hospital Leicester NHS Trust
Leicester, United Kingdom
-
University Medical Center Groningen
Groningen, Netherlands
-
University of Iowa Stead Family Chlldren's Hospital
Iowa City, Iowa, 52242, United States
-
University of Malaysia Medical Center
Kuala Lumpur, Malaysia
More trials for these conditions
Other studies related to the condition(s) this trial covers.