PROSpect: Prone and Oscillation Pediatric Clinical Trial

Summary

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).

Conditions

• Acute Respiratory Distress Syndrome in Children

Interventions

OTHER

Either supine or prone positioning and either CMV or HFOV

Supine positioning: Subjects randomized to supine positioning will remain supine. Prone positioning: Subjects randomized to prone positioning will be positioned prone ≥16 hours/day for a maximum of 28 days. CMV strategy: Low tidal volume to obtain exhaled Vt of 5-7 ml/kg (ideal body weight), PIP goal limited to ≤ 28 cm H2O and lung recruitment maneuver to identify best PEEP then maintained per PEEP-FiO2 grid. HFOV strategy: Frequency at 8-12 Hz, amplitude (delta-P) 60-90 and mPaw recruitment maneuver.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University Medical Center Groningen

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Martha AQ Curley, RN, PhD · University of Pennsylvania

• Ira M. Cheifetz, MD · UH Rainbow Babies and Children's Hospital

• Martin CJ Kneyber, MD, PhD · Beatrix Children's Hospital

• David Wypij, PhD · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

2 Weeks

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2026-02-13

Completion

2027-01-31

Countries

• United States
• Argentina
• Australia
• Brazil
• Canada
• Germany
• India
• Israel
• Italy
• Malaysia
• Netherlands
• South Korea
• Thailand
• United Arab Emirates
• United Kingdom

Study Locations