# 1/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (CCC)

> **NIH NIH UH3** · UNIVERSITY OF PENNSYLVANIA · 2021 · $1,742,161

## Abstract

Project Summary
Although acute respiratory distress syndrome is a life-threatening and frequent problem experienced by
thousands of children each year, little evidence supports best ventilation practices during their critical illness.
For over 25 years, pediatric critical care clinicians have debated the risk-benefit ratio of supine versus prone
positioning and conventional mechanical ventilation (CMV) versus high-frequency oscillatory ventilation
(HFOV) in the management of these young patients. Without pediatric-specific data, the debate of how best to
care for children with severe Pediatric Acute Respiratory Distress Syndrome (PARDS) will continue and
prevent progress in the field of pediatric critical care.
We propose PROSpect (PRone and OScillation PEdiatric Clinical Trial), a two-by-two factorial, response-
adaptive, randomized controlled clinical trial of supine/prone positioning and CMV/HFOV. Forty-five pediatric
intensive care units (PICUs), 30 U.S. and 15 international (2/3:1/3 split), with at least 5 years of experience
with prone positioning and HFOV in the care of pediatric patients with severe PARDS, that can provide back-
up extracorporeal membrane oxygenation (ECMO) support will participate. Eligible consecutive subjects with
severe PARDS will be randomized within 48 hours of meeting eligibility criteria and within 4 days of
endotracheal intubation to one of four groups: supine/CMV, prone/CMV, supine/HFOV, prone/HFOV. Subjects
who fail their assigned positional and/or ventilation therapy for either persistent hypoxia or hypercapnia may
receive the reciprocal therapy while being considered for ECMO cannulation. Our primary outcome is
ventilator-free days (VFD), where non-survivors receive zero VFDs. We hypothesize that children with severe
PARDS treated with either prone positioning or HFOV will demonstrate ≥2 more VFDs. Our secondary
outcome is nonpulmonary organ failure-free days. We will also explore the interaction effects of prone
positioning with HFOV on VFDs and also investigate the impact of these interventions on 90-day in-hospital
mortality and, among survivors, the duration of mechanical ventilation, PICU and hospital length of stay, and
the trajectory of post-PICU functional status and health-related quality of life (HRQL). Up to 1000 subjects with
severe PARDS will be randomized by age group and direct/indirect lung injury. Adaptive randomization will
begin after 400 subjects provide complete data on VFDs. Any group demonstrating inferiority at a pre-planned
adaptive randomization update analysis will be eliminated to increase allocation to the superior group(s). Data
will be analyzed per intention-to-treat and per-protocol received.
This clinical trial will provide the definitive evidence necessary for the field to consider a major change
in clinical practice in the care of critically ill children with severe PARDS.

## Key facts

- **NIH application ID:** 10219895
- **Project number:** 5UH3HL141736-04
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Ira M Cheifetz
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,742,161
- **Award type:** 5
- **Project period:** 2018-06-15 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10219895

## Citation

> US National Institutes of Health, RePORTER application 10219895, 1/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (CCC) (5UH3HL141736-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10219895. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*