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Prone Positioning + HFOV for Severe Pediatric ARDS

N/A

Waitlist Available

Led By Ira M. Cheifetz, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

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)

Must not have

Currently receiving more than 6 consecutive hours of either prone positioning or HFOV

Unstable spine, femur or pelvic fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 12 months post picu discharge

Awards & highlights

Summary

This trial is testing whether two different types of respiratory support - prone positioning or high-frequency oscillatory ventilation (HFOV) - are better than the current standard of care for children with severe PARDS.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from position changes, skin issues at pressure points due to prolonged positioning, and risks associated with different types of mechanical ventilation such as lung injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have been diagnosed with bronchiolitis obliterans.

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I have a heart condition that causes bluish skin color.

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I have a critical airway condition or a blockage in my lower airway.

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I have an open wound in my abdomen.

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I have severe lung disease without lung tissue involvement.

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I have been diagnosed with cardiomyopathy.

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I am currently on a breathing machine due to severe asthma.

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I have a muscle condition that affects my breathing.

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I have had bleeding in my brain.

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My lung disease affects only one lung.

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I have high blood pressure in the lungs not caused by another condition.

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I have had a lung transplant.

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I have an untreated hole in my diaphragm or my diaphragm cannot move.

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My breathing problems are due to heart failure or fluid buildup.

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I have had a head injury treated with hyperventilation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 12 months post picu discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 12 months post picu discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12 months post picu discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ventilator - respiratory equipment

Secondary study objectives

Nonpulmonary organ failure-free days (OFFD)

Other study objectives

90-day in-hospital mortality

Duration of mechanical ventilation (among survivors)

Interaction effects of prone positioning with HFOV on VFDs - number of ventilator-free days

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Supine / HVOFExperimental Treatment1 Intervention

Supine positioning and high-frequency oscillatory ventilation

Group II: Supine / CMVExperimental Treatment1 Intervention

Supine positioning and conventional mechanical ventilation

Group III: Prone / HFOVExperimental Treatment1 Intervention

Prone positioning and high-frequency oscillatory ventilation

Group IV: Prone / CMVExperimental Treatment1 Intervention

Prone positioning and conventional mechanical ventilation

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Medical Center GroningenOTHER

740 Previous Clinical Trials

1,027,964 Total Patients Enrolled

University Hospitals Cleveland Medical CenterOTHER

320 Previous Clinical Trials

339,388 Total Patients Enrolled

Boston Children's HospitalOTHER

778 Previous Clinical Trials

5,580,412 Total Patients Enrolled

~112 spots leftby Jan 2026

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