Prone Positioning + HFOV for Severe Pediatric ARDS

Enrolling by invitation at 76 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Cardiac failure, Cyanotic heart disease, Neuromuscular respiratory failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different ventilation techniques and body positions can help children with severe pediatric acute respiratory distress syndrome (PARDS) breathe better and reduce ventilator time. Researchers compare prone positioning and high-frequency oscillatory ventilation (HFOV) with supine positioning and conventional mechanical ventilation (CMV) to determine the best approach. Children who have been on a ventilator with moderate to severe PARDS for less than 48 hours qualify as candidates. As an unphased trial, this study provides a unique opportunity to contribute to vital research that could enhance treatment strategies for children with PARDS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these ventilation and positioning techniques are safe for children with severe PARDS?

Research has shown that using high-frequency oscillatory ventilation (HFOV) along with prone positioning can improve oxygen levels in babies with severe lung problems (ARDS). Importantly, this combination did not cause any serious issues in these cases. Placing patients on their stomachs alone has been proven to help with oxygen levels, although it doesn't necessarily shorten the time they need breathing support.

For those considering HFOV, studies have found that it maintains the oxygen benefits from prone positioning even when patients are turned onto their backs. Regarding safety, these treatments have been used without major side effects, making them generally safe options for managing serious breathing problems in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial combining prone positioning with high-frequency oscillatory ventilation (HFOV) for severe pediatric ARDS because it offers a unique approach compared to traditional methods. Conventional treatments usually rely on supine positioning with standard mechanical ventilation. Prone positioning is believed to improve oxygenation by redistributing lung pressures and enhancing lung recruitment. Meanwhile, HFOV delivers small, rapid breaths, which can minimize lung injury. By combining these strategies, the trial aims to optimize lung function and potentially improve outcomes for children with severe ARDS.

What evidence suggests that this trial's treatments could be effective for severe pediatric ARDS?

Research has shown that lying face down, known as prone positioning, can greatly improve oxygen levels in patients with acute respiratory distress syndrome (ARDS). In this trial, some participants will receive prone positioning combined with high-frequency oscillatory ventilation (HFOV), which has helped infants breathe better after heart surgery without causing serious side effects. Other participants will receive prone positioning with conventional mechanical ventilation (CMV), which studies suggest can increase oxygen levels, though it might not reduce the time patients need the machine. Longer use of prone positioning is linked to lower death rates in ICU patients with ARDS. Overall, both prone positioning and HFOV appear promising in helping children with serious breathing issues breathe easier and recover faster. ^{1 3 4 5 6}

Who Is on the Research Team?

Ira M. Cheifetz, MD

Principal Investigator

UH Rainbow Babies and Children's Hospital

Martha AQ Curley, RN, PhD

Principal Investigator

University of Pennsylvania

David Wypij, PhD

Principal Investigator

Boston Children's Hospital

Martin CJ Kneyber, MD, PhD

Principal Investigator

Beatrix Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children with severe PARDS, intubated and ventilated for less than 48 hours. They must meet specific criteria indicating lung distress and not have conditions like intracranial bleeding, obstructive airway disease, recent facial trauma, unstable fractures, certain heart diseases or be on other trials.

Inclusion Criteria

I have been on a ventilator for less than 48 hours due to severe lung issues.

I have had two blood gas tests showing moderate to severe lung issues, following specific lung treatment guidelines.

You don't need to have another blood gas test if your oxygen index is 16 or higher.

Exclusion Criteria

I am currently undergoing treatments that require me to be in a specific position for more than 6 hours.

I have stable fractures in my spine, femur, or pelvis.

I have been diagnosed with bronchiolitis obliterans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of four groups: supine/CMV, prone/CMV, supine/HFOV, prone/HFOV, and receive positional and/or ventilation therapy

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ventilator-free days and nonpulmonary organ failure-free days

90 days

Post-PICU Discharge Monitoring

Functional status and health-related quality of life are assessed at multiple intervals post PICU discharge

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Mechanical Ventilation (CMV)
• High-Frequency Oscillatory Ventilation (HFOV)
• Prone Positioning
• Supine Positioning

Trial Overview The study tests whether prone positioning or high-frequency oscillatory ventilation (HFOV) improves outcomes in children with PARDS compared to supine positioning or conventional mechanical ventilation (CMV). The goal is more days off the ventilator.

How Is the Trial Designed?

Group I: Supine / HVOF Experimental Treatment 1 Intervention

Supine positioning and high-frequency oscillatory ventilation

Group II: Supine / CMV Experimental Treatment 1 Intervention

Supine positioning and conventional mechanical ventilation

Group III: Prone / HFOV Experimental Treatment 1 Intervention

Prone positioning and high-frequency oscillatory ventilation

Group IV: Prone / CMV Experimental Treatment 1 Intervention

Prone positioning and conventional mechanical ventilation

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

University Medical Center Groningen

Collaborator

Trials

770

Recruited

1,101,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955119/

Prone position in the mechanical ventilation of acute ... Prone position ventilation has obvious advantages in improving oxygenation, but there is no significant improvement in the time of mechanical ventilation.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38516357/

Prone position in the mechanical ventilation of acute ... Prone position ventilation has obvious advantages in improving oxygenation, but there is no significant improvement in the time of ...

3. jintensivecare.biomedcentral.com jintensivecare.biomedcentral.com/articles/10.1186/s40560-025-00795-x

The effects of prolonged prone positioning on response and ... PPP (≥ 16 h) is associated with reduced 28-day mortality and improved response rates in ICU patients with ARDS, without increasing complication risks.

4. semanticscholar.org semanticscholar.org/paper/Prone-position-in-the-mechanical-ventilation-of-a-Qin-Mao/dedbcce362cea8c87e849d915e71bf0b84644cfb

[PDF] Prone position in the mechanical ventilation of acute ... Pone position ventilation has obvious advantages in improving oxygenation, but there is no significant improvement in the time of mechanical ventilation in ...

5. cmaj.ca cmaj.ca/content/186/10/e381

Effect of prone positioning during mechanical ventilation ... Our analysis of high-quality evidence showed that use of the prone position during mechanical ventilation improved survival among patients with ARDS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5949405/

Prone positioning in acute respiratory distress syndrome A number of recent studies have examined the impact of prone positioning (PP) in ARDS as a life-saving intervention.