Prone Positioning + HFOV for Severe Pediatric ARDS

Recruiting at72 trial locations

Overseen by Martin CJ Kneyber, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

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).

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

Eligibility Criteria

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.

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

University Medical Center Groningen

Collaborator

Trials

770

Recruited

1,101,000+

Henk Heidekamp

University Medical Center Groningen

Chief Executive Officer since 2014

MSc in Toxicology and Nutrition from the Open University of the Netherlands

Paulina Snijders

University Medical Center Groningen

Chief Medical Officer since 2023

MD

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Dr. Brett Glotzbecker

University Hospitals Cleveland Medical Center

Chief Medical Officer since 2023

MD

Dr. Cliff Megerian

University Hospitals Cleveland Medical Center

Chief Executive Officer

MD, MBA

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Dr. Kevin B. Churchwell

Boston Children's Hospital

Chief Executive Officer since 2021

MD from Vanderbilt Medical School

Dr. Sarah Pitts

Boston Children's Hospital

Chief Medical Officer since 2019

MD from Harvard Medical School

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco