Acute Respiratory Distress Syndrome in ChildrenNCT03896763
PROSpect: Prone and Oscillation Pediatric Clinical Trial
A study testing Either supine or prone positioning and either CMV or HFOV in people with Acute Respiratory Distress Syndrome in Children, run by University of Pennsylvania at 49 sites in 15 countries.
Trial summary
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. Read more about this study
- Who is it for?
- Ages 2 weeks to 20 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome in Children
- What is being tested?
- Either supine or prone positioning and either CMV or HFOV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 49 sitesin 15 countries
- Study dates
- 1 May 2019to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
49 sites in 15 countries.
49 sites in 15 countries
United States28 sites
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Bloomberg Children's Center, Johns Hopkins University
Baltimore, Maryland, 21287
Children's of Alabama
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
UH Rainbow Babies & Children
Cleveland, Ohio, 44106
Medical City Dallas
Dallas, Texas, 75230
Children's Health Dallas
Dallas, Texas, 75235
Duke Children's Hospital
Durham, North Carolina, 27710
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
University of Iowa Stead Family Chlldren's Hospital
Iowa City, Iowa, 52242
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Norton Children's Hospital
Louisville, Kentucky, 40202
American Family Children's Hospital, University of Wisconsin
Madison, Wisconsin, 53792
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital and Medical Center
Omaha, Nebraska, 68198
Children's Hospital Orange County
Orange, California, 92868
Stanford Children's Health
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014
Banner Health
Phoenix, Arizona, 85006
Cohen Children's Medical Center
Queens, New York, 11040
Children's Hospital of San Antonio
San Antonio, Texas, 78207
Italy3 sites
Meyer Children's Hospital
Florence, Italy
Instituto Giannina Gasilini
Genova
Bambino Gesu Children's Hospital (Area Rossa Unit)
Rome, Italy
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Faculty of Medicine Ramathibodi Hospital
Bangkok
Australia2 sites
Perth Children's Hospital
Perth, Western Australia, 6840
Children's Hospital at Westmead
Sydney
Brazil2 sites
Sabara Hospital Infantil
São Paulo, Brazil
Hospital SEPACO
São Paulo
United Kingdom2 sites
Birmingham Children's Hospital
Birmingham, UK
University Hospital Leicester NHS Trust
Leicester
Argentina1 site
Hospital de Pediatría J. P. Garrahan. SAMIC
Buenos Aires, Buenos Aires F.D., C1245AAM
Canada1 site
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T1C5
About this study
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).
Read the detailed description
PROSpect is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV). About 60 pediatric intensive care units (PICUs), two thirds U.S. and one third international, with at least 5 years of experience with prone positioning and HFOV in the care of pediatric patients with severe Pediatric Acute Respiratory Distress Syndrome (PARDS), that can provide back-up extracorporeal membrane oxygenation (ECMO) support, are participating. Eligible consecutive subjects with high moderate-severe PARDS will be randomized to one of four groups: supine/CMV, prone/CMV, supine/HFOV, prone/HFOV. Subjects who fail their assigned positional and/or ventilation therapy for either persistent hypoxia or hypercapnia may receive the reciprocal therapy while being considered for ECMO cannulation. Our primary outcome is ventilator-free days (VFD) through day 28, where non-survivors receive zero VFD. We hypothesize that children with severe PARDS treated with either prone positioning or HFOV will demonstrate ≥ 2 more VFD. Our secondary outcome is nonpulmonary organ failure-free days. We will also explore the interaction effects of prone positioning with HFOV on VFDs and also investigate the impact of these interventions on 90-day in-hospital mortality and, among survivors, the duration of mechanical ventilation, PICU and hospital length of stay, and the trajectory of post-PICU functional status and health-related quality of life (HRQL). Up to 600 subjects with severe PARDS will be randomized, stratified by age group and direct/indirect lung injury. Adaptive randomization will first occur after 300 patients are randomized and have been followed for 28 days, and every 100 patients thereafter. At these randomization update analyses, new allocation probabilities will be computed based on ongoing intention-to-treat trial results, increasing allocation to well performing arms and decreasing allocation to poorly performing arms. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol received for primary, secondary and exploratory analyses.
- Being tested
- Either supine or prone positioning and either CMV or HFOV
- Keywords
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, child, pediatric intensive care unit
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Either supine or prone positioning and either CMV or HFOVOther
Also called Supine positioning, Prone positioing, Conventional mechanical ventilation (CMV), High frequency oscillatory ventilation (HFOV)
Supine positioning: Subjects randomized to supine positioning will remain supine.
Prone positioning: Subjects randomized to prone positioning will be positioned prone ≥16 hours/day for a maximum of 28 days.
CMV strategy: Low tidal volume to obtain exhaled Vt of 5-7 ml/kg (ideal body weight), PIP goal limited to ≤ 28 cm H2O and lung recruitment maneuver to identify best PEEP then maintained per PEEP-FiO2 grid.
HFOV strategy: Frequency at 8-12 Hz, amplitude (delta-P) 60-90 and mPaw recruitment maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Supine / CMV | Experimental | Supine positioning and conventional mechanical ventilation Receives: Other: Either supine or prone positioning and either CMV or HFOV |
| Prone / CMV | Experimental | Prone positioning and conventional mechanical ventilation Receives: Other: Either supine or prone positioning and either CMV or HFOV |
| Supine / HVOF | Experimental | Supine positioning and high-frequency oscillatory ventilation Receives: Other: Either supine or prone positioning and either CMV or HFOV |
| Prone / HFOV | Experimental | Prone positioning and high-frequency oscillatory ventilation Receives: Other: Either supine or prone positioning and either CMV or HFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free Days (VFD)
Our primary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more ventilator-free days. We hypothesize that a superior treatment would improve VFD by at least 2 days, a clinically meaningful difference. VFD is the number of days within 28 days that a patient is alive and free of mechanical ventilation. Improvement in VFD will be considered within the context of patient safety; specifically, patients must also exhibit a similar safety profile.
Measured: 28 days
Secondary outcomes (1)
Nonpulmonary organ failure-free days (OFFD)
Our secondary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more more nonpulmonary organ failure-free days. OFFD is the number of days within 28 days that a patient is alive and free of clinically significant non-pulmonary organ failure. Nonpulmonary organ failure-free days will be calculated based on the clinically important nonpulmonary organ systems (neurologic, cardiovascular, renal and hematologic) using nonpulmonary PEdiatric Logistic Organ Dysfunction-2 (PELOD-20 scores.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 May 2019
- Primary completion13 Feb 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two-by-two factorial, response-adaptive, randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University Medical Center Groningen, Boston Children's Hospital, University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Martha A.Q. Curley, PhD, RN, University of Pennsylvania
- Investigators
- Martha AQ Curley, RN, PhD, Principal investigator, University of PennsylvaniaIra M. Cheifetz, MD, Principal investigator, UH Rainbow Babies and Children's HospitalMartin CJ Kneyber, MD, PhD, Principal investigator, Beatrix Children's HospitalDavid Wypij, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896763
- Sponsor's protocol ID
- 831295
- Other IDs
- 5UH3HL141736-03
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per NHLBI policy, we will provide a deidentified dataset and all the data-related documentation necessary to utilize the study data (dictionary, calculated variables and standard operating procedures) to the NHLBI. We will submit this dataset to the NHLBI Data Repository managed by the BioLINCC (Biologic Specimen and Data Repository Information Coordinating Center).
Publications
Kalvas LB, Perry-Eaddy MA, Cassidy A, Dawkins-Henry OS, Lee L, Asaro LA, Wypij D, Curley MAQ. Considerations in Launching an International Multisite Clinical Trial. Nurs Res. 2025 Sep-Oct 01;74(5):391-398. doi: 10.1097/NNR.0000000000000826. Epub 2025 Apr 4.
PubMed 40203841Kneyber MCJ, Cheifetz IM, Asaro LA, Graves TL, Viele K, Natarajan A, Wypij D, Curley MAQ; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Protocol for the Prone and Oscillation Pediatric Clinical Trial ( PROSpect ). Pediatr Crit Care Med. 2024 Sep 1;25(9):e385-e396. doi: 10.1097/PCC.0000000000003541. Epub 2024 May 28.
PubMed 38801306Curley MAQ, Kneyber MCJ, Cheifetz IM, Kong M, Mahapatra S, Schwarz AJ, Phumeetham S, Irby K, Napolitano N, Dawkins-Henry OS, Birch EE, Elliott CF, Berry LR, Downes KJ, Natarajan A, Detry MA, Viele K, Graves TL, Matthay M, Asaro LA, Wypij D; PROSpect Study Investigators; Paediatric Acute Lung Injury and Sepsis Investigators Network. Prone positioning and high-frequency oscillatory ventilation in early paediatric acute respiratory distress syndrome (PROSpect): an international, two-by-two factorial, response-adaptive, phase 3, randomised controlled trial. Lancet. 2026 Oct 31;408(10566):1815-1827. doi: 10.1016/S0140-6736(26)01949-5.
PubMed 42956771
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSpect: Prone and Oscillation Pediatric Clinical Trial
- ClinicalTrials.gov ID
- NCT03896763
- Acronym / sponsor ID
- 831295
- Keywords
- Pediatric Acute Respiratory Distress Syndrome (PARDS), Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, child, pediatric intensive care unit
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University Medical Center Groningen, Boston Children's Hospital, University Hospitals Cleveland Medical Center
- Study start
- 1 May 2019 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year. Little evidence supports current supportive practices during their critical illness. The overall objective of this study is to identify the best positional and/or ventilation practice that leads to improved patient outcomes in these critically ill children. We hypothesize that children with high moderate-severe PARDS treated with either prone positioning or high-frequency oscillatory ventilation (HFOV) will demonstrate more days off the ventilator when compared to children treated with supine positioning or conventional mechanical ventilation (CMV).
Detailed description
PROSpect is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV). About 60 pediatric intensive care units (PICUs), two thirds U.S. and one third international, with at least 5 years of experience with prone positioning and HFOV in the care of pediatric patients with severe Pediatric Acute Respiratory Distress Syndrome (PARDS), that can provide back-up extracorporeal membrane oxygenation (ECMO) support, are participating. Eligible consecutive subjects with high moderate-severe PARDS will be randomized to one of four groups: supine/CMV, prone/CMV, supine/HFOV, prone/HFOV. Subjects who fail their assigned positional and/or ventilation therapy for either persistent hypoxia or hypercapnia may receive the reciprocal therapy while being considered for ECMO cannulation. Our primary outcome is ventilator-free days (VFD) through day 28, where non-survivors receive zero VFD. We hypothesize that children with severe PARDS treated with either prone positioning or HFOV will demonstrate ≥ 2 more VFD. Our secondary outcome is nonpulmonary organ failure-free days. We will also explore the interaction effects of prone positioning with HFOV on VFDs and also investigate the impact of these interventions on 90-day in-hospital mortality and, among survivors, the duration of mechanical ventilation, PICU and hospital length of stay, and the trajectory of post-PICU functional status and health-related quality of life (HRQL). Up to 600 subjects with severe PARDS will be randomized, stratified by age group and direct/indirect lung injury. Adaptive randomization will first occur after 300 patients are randomized and have been followed for 28 days, and every 100 patients thereafter. At these randomization update analyses, new allocation probabilities will be computed based on ongoing intention-to-treat trial results, increasing allocation to well performing arms and decreasing allocation to poorly performing arms. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol received for primary, secondary and exploratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two-by-two factorial, response-adaptive, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Supine / CMV | Experimental | Other: Either supine or prone positioning and either CMV or HFOVSupine positioning and conventional mechanical ventilation |
| Prone / CMV | Experimental | Other: Either supine or prone positioning and either CMV or HFOVProne positioning and conventional mechanical ventilation |
| Supine / HVOF | Experimental | Other: Either supine or prone positioning and either CMV or HFOVSupine positioning and high-frequency oscillatory ventilation |
| Prone / HFOV | Experimental | Other: Either supine or prone positioning and either CMV or HFOVProne positioning and high-frequency oscillatory ventilation |
Who may qualify
- Ages
- 2 weeks to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Either supine or prone positioning and either CMV or HFOVAlso: Supine positioning, Prone positioing, Conventional mechanical ventilation (CMV), High frequency oscillatory ventilation (HFOV)Supine positioning: Subjects randomized to supine positioning will remain supine. Prone positioning: Subjects randomized to prone positioning will be positioned prone ≥16 hours/day for a maximum of 28 days. CMV strategy: Low tidal volume to obtain exhaled Vt of 5-7 ml/kg (ideal body weight), PIP goal limited to ≤ 28 cm H2O and lung recruitment maneuver to identify best PEEP then maintained per PEEP-FiO2 grid. HFOV strategy: Frequency at 8-12 Hz, amplitude (delta-P) 60-90 and mPaw recruitment maneuver. | Other | Prone / CMV, Prone / HFOV, Supine / CMV, Supine / HVOF |
Primary outcome
Ventilator-free Days (VFD)
Time frame: 28 days
Our primary research hypothesis is that children with severe PARDS randomized to either prone positioning or HFOV will demonstrate more ventilator-free days. We hypothesize that a superior treatment would improve VFD by at least 2 days, a clinically meaningful difference. VFD is the number of days within 28 days that a patient is alive and free of mechanical ventilation. Improvement in VFD will be considered within the context of patient safety; specifically, patients must also exhibit a similar safety profile.
1 secondary outcome
Nonpulmonary organ failure-free days (OFFD)
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 40203841Kalvas LB, Perry-Eaddy MA, Cassidy A, Dawkins-Henry OS, Lee L, Asaro LA, Wypij D, Curley MAQ. Considerations in Launching an International Multisite Clinical Trial. Nurs Res. 2025 Sep-Oct 01;74(5):391-398. doi: 10.1097/NNR.0000000000000826. Epub 2025 Apr 4.
- Background: PubMed 38801306Kneyber MCJ, Cheifetz IM, Asaro LA, Graves TL, Viele K, Natarajan A, Wypij D, Curley MAQ; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Protocol for the Prone and Oscillation Pediatric Clinical Trial ( PROSpect ). Pediatr Crit Care Med. 2024 Sep 1;25(9):e385-e396. doi: 10.1097/PCC.0000000000003541. Epub 2024 May 28.
- Derived from this study: PubMed 42956771Curley MAQ, Kneyber MCJ, Cheifetz IM, Kong M, Mahapatra S, Schwarz AJ, Phumeetham S, Irby K, Napolitano N, Dawkins-Henry OS, Birch EE, Elliott CF, Berry LR, Downes KJ, Natarajan A, Detry MA, Viele K, Graves TL, Matthay M, Asaro LA, Wypij D; PROSpect Study Investigators; Paediatric Acute Lung Injury and Sepsis Investigators Network. Prone positioning and high-frequency oscillatory ventilation in early paediatric acute respiratory distress syndrome (PROSpect): an international, two-by-two factorial, response-adaptive, phase 3, randomised controlled trial. Lancet. 2026 Oct 31;408(10566):1815-1827. doi: 10.1016/S0140-6736(26)01949-5.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Per NHLBI policy, we will provide a deidentified dataset and all the data-related documentation necessary to utilize the study data (dictionary, calculated variables and standard operating procedures) to the NHLBI. We will submit this dataset to the NHLBI Data Repository managed by the BioLINCC (Biologic Specimen and Data Repository Information Coordinating Center).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha AQ Curley, RN, PhD principal investigator
University of Pennsylvania
Ira M. Cheifetz, MD principal investigator
UH Rainbow Babies and Children's Hospital
Martin CJ Kneyber, MD, PhD principal investigator
Beatrix Children's Hospital
49 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Either supine or prone positioning and either CMV or HFOV in people with Acute Respiratory Distress Syndrome in Children, run by University of Pennsylvania at 49 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Italy, Thailand, Australia, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free Days (VFD) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03896763, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.