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Prone Positioning + HFOV for Severe Pediatric ARDS

Q: What is the scope of this experiment, in terms of how many healthcare facilities are involved?

This clinical trial is being conducted in multiple locations, including The Children's Hospital of Montefiore in Bronx, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>; UC Davis Medical Center in Sacramento, <a href="https://www.withpower.com/clinical-trials/california">California</a>; and UNC Chapel Hill in Chapel Hill, <a href="https://www.withpower.com/clinical-trials/virginia">Virginia</a>. Additionally there are other 38 sites across the nation participating as well.

Q: Are there still openings to participate in this investigation?

According to clinicaltrials.gov, this medical experiment is not open for recruitment at present. The study, published on May 1st 2019 and last amended August 26th 2022, has concluded its participant enrollment phase; however, there are 1521 other active trials that may be of interest.

Q: Is eligibility for this research study restricted to those over 18 years of age?

According to the criteria for inclusion in this trial, prospective participants must be between 2 weeks and 20 years of age. There are 410 trials catering to minors while a whopping 1078 clinical trials target people aged 65 and above.

Q: Is there an opportunity to participate in this medical experiment?

For eligibility in this medical experiment, participants must possess respiratory distress syndrome and be infants between 2 Weeks and 20 weeks of age. This research study is recruiting approximately 800 individuals.

N/A

Waitlist Available

Led By Martha AQ Curley, RN, PhD

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ventilator - respiratory equipment

Secondary outcome measures

Nonpulmonary organ failure-free days (OFFD)

Other outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Medical Center GroningenOTHER

711 Previous Clinical Trials

975,997 Total Patients Enrolled

University Hospitals Cleveland Medical CenterOTHER

317 Previous Clinical Trials

339,457 Total Patients Enrolled

Boston Children's HospitalOTHER

760 Previous Clinical Trials

5,578,880 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this experiment, in terms of how many healthcare facilities are involved?

"This clinical trial is being conducted in multiple locations, including The Children's Hospital of Montefiore in Bronx, New york; UC Davis Medical Center in Sacramento, California; and UNC Chapel Hill in Chapel Hill, Virginia. Additionally there are other 38 sites across the nation participating as well."

Answered by AI

Are there still openings to participate in this investigation?

"According to clinicaltrials.gov, this medical experiment is not open for recruitment at present. The study, published on May 1st 2019 and last amended August 26th 2022, has concluded its participant enrollment phase; however, there are 1521 other active trials that may be of interest."

Answered by AI

Is eligibility for this research study restricted to those over 18 years of age?

"According to the criteria for inclusion in this trial, prospective participants must be between 2 weeks and 20 years of age. There are 410 trials catering to minors while a whopping 1078 clinical trials target people aged 65 and above."

Answered by AI

Is there an opportunity to participate in this medical experiment?

"For eligibility in this medical experiment, participants must possess respiratory distress syndrome and be infants between 2 Weeks and 20 weeks of age. This research study is recruiting approximately 800 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROSpect: Prone and Oscillation Pediatric Clinical Trial

Martha A.Q. Curley, PhD, RN 2019. "PROSpect: Prone and Oscillation Pediatric Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896763.

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