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Protocol for the Prone and Oscillation Pediatric Clinical Trial ( PROSpect )
Martin C J Kneyber1,2, Ira M Cheifetz3, Lisa A Asaro4
1Division of Pediatric Critical Care Medicine, Department of Pediatrics, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Insights
This study investigates prone positioning (PP) and high-frequency oscillatory ventilation (HFOV) for pediatric acute respiratory distress syndrome (PARDS). Results will guide clinical practice for these critical respiratory management strategies.
Area of Science:
- Critical Care Medicine
- Pediatric Pulmonology
- Clinical Trials Methodology
Background:
- Current respiratory management for pediatric acute respiratory distress syndrome (PARDS) is primarily supportive.
- Limited data exists to guide the choice between supine and prone positioning (PP) or conventional mechanical ventilation (CMV) and high-frequency oscillatory ventilation (HFOV).
Purpose of the Study:
- To compare the efficacy of prone positioning (PP) versus supine positioning and high-frequency oscillatory ventilation (HFOV) versus conventional mechanical ventilation (CMV) in pediatric patients with moderate-to-severe PARDS.
- To provide evidence-based guidance for respiratory management strategies in critically ill children.
Main Methods:
- A global, multicenter, two-by-two factorial, response-adaptive randomized controlled trial (PROSpect) involving approximately 60 PICUs.
- Pediatric patients (≥2 weeks old) with moderate-to-severe PARDS randomized to one of four arms: supine/CMV, prone/CMV, supine/HFOV, or prone/HFOV.
- Hypothesis: PP or HFOV will result in at least 2 additional ventilator-free days (VFD) compared to standard care.
Main Results:
- The primary outcome is ventilator-free days (VFD) through day 28, with nonsurvivors receiving zero VFD.
- Secondary outcomes include nonpulmonary organ failure-free days, 90-day mortality, and post-PICU functional status.
- Adaptive randomization will adjust treatment allocation probabilities based on accumulating trial data.
Conclusions:
- The PROSpect trial aims to generate crucial data to inform clinical decision-making regarding prone positioning and high-frequency oscillatory ventilation in PARDS.
- Findings will support evidence-based respiratory care for critically ill children with PARDS.
Objectives:
Respiratory management for pediatric acute respiratory distress syndrome (PARDS) remains largely supportive without data to support one approach over another, including supine versus prone positioning (PP) and conventional mechanical ventilation (CMV) versus high-frequency oscillatory ventilation (HFOV).
Design:
We present the research methodology of a global, multicenter, two-by-two factorial, response-adaptive, randomized controlled trial of supine versus PP and CMV versus HFOV in high moderate-severe PARDS, the Prone and Oscillation Pediatric Clinical Trial ( PROSpect , www.ClinicalTrials.gov , NCT03896763).
Setting:
Approximately 60 PICUs with on-site extracorporeal membrane oxygenation support in North and South America, Europe, Asia, and Oceania with experience using PP and HFOV in the care of patients with PARDS.
Patients:
Eligible pediatric patients (2 wk old or older and younger than 21 yr) are randomized within 48 h of meeting eligibility criteria occurring within 96 h of endotracheal intubation.
Interventions:
One of four arms, including supine/CMV, prone/CMV, supine/HFOV, or prone/HFOV. We hypothesize that children with high moderate-severe PARDS treated with PP or HFOV will demonstrate greater than or equal to 2 additional ventilator-free days (VFD).
Measurements And Main Results:
The primary outcome is VFD through day 28; nonsurvivors receive zero VFD. Secondary and exploratory outcomes include nonpulmonary organ failure-free days, interaction effects of PP with HFOV on VFD, 90-day in-hospital mortality, and among survivors, duration of mechanical ventilation, PICU and hospital length of stay, and post-PICU functional status and health-related quality of life. Up to 600 patients will be randomized, stratified by age group and direct/indirect lung injury. Adaptive randomization will first occur 28 days after 300 patients are randomized and every 100 patients thereafter. At these randomization updates, new allocation probabilities will be computed based on intention-to-treat trial results, increasing allocation to well-performing arms and decreasing allocation to poorly performing arms. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol for primary, secondary, and exploratory analyses.
Conclusions:
PROSpect will provide clinicians with data to inform the practice of PP and HFOV in PARDS.
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