Prone Positioning + HFOV for Severe Pediatric ARDS

Recruiting at 73 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

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

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

Is prone positioning with high-frequency oscillatory ventilation safe for children with severe ARDS?

High-frequency oscillation (HFO) is used as a rescue support, but about one-third of survivors may have abnormal neurodevelopmental findings later on. ^{1 2 3 4 5}

How is the treatment of prone positioning combined with high-frequency oscillatory ventilation (HFOV) unique for severe pediatric ARDS?

This treatment is unique because it combines prone positioning (lying face down) with high-frequency oscillatory ventilation (HFOV), which helps keep the lungs open and improves oxygen levels. This combination can be more effective in improving breathing and protecting the lungs compared to using each method alone. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Prone Positioning + HFOV for Severe Pediatric ARDS?

Research shows that both prone positioning and high-frequency oscillatory ventilation (HFOV) can improve lung function and oxygen levels in patients with acute respiratory distress syndrome (ARDS). Combining these treatments may help keep the lungs open and improve breathing, which is especially important for severe cases. ^{6 7 8 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Comparison of prone positioning and high-frequency oscillatory ventilation in patients with acute respiratory distress syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

High-frequency oscillatory ventilation following prone positioning prevents a further impairment in oxygenation. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Indications for Proning in Acute Respiratory Distress Syndrome: Expanding the Horizon! [2022]

4. China pubmed.ncbi.nlm.nih.gov

[A Meta analysis of the efficacy of high-frequency oscillatory ventilation versus conventional mechanical ventilation for treating pediatric acute respiratory distress syndrome]. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

High-frequency oscillatory ventilation and adjunctive therapies: inhaled nitric oxide and prone positioning. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Characterization of Death in Neonatal Encephalopathy in the Hypothermia Era. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of electroencephalograms in asphyxiated newborns treated with hypothermia. [2008]

8. Ireland pubmed.ncbi.nlm.nih.gov

Rescue high frequency oscillation and predictors of adverse neurodevelopmental outcome in preterm infants. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Current controversies in hypothermic neuroprotection. [2007]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Successful Whole Body Therapeutic Hypothermia for Hypoxic Ischemic Encephalopathy During an ECMO Run in a Newborn. [2020]