PROSpect: Prone and Oscillation Pediatric Clinical Trial

Running, not enrolling · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome in Children

In brief

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).

Key facts

Study ID

NCT03896763

Run by

University of Pennsylvania

People needed

600

Starts

2019-05-01

Expected to finish

2027-01-31

Last updated by the study team

2026-05-05

Who can join

Age: 0 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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). We require 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). A second blood gas is not required for OI ≥16.

You may not qualify if…

• Perinatal related lung disease
• Unrepaired congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
• Respiratory failure explained by cardiac failure or fluid overload
• Cyanotic heart disease
• Cardiomyopathy
• Unilateral lung disease
• Primary pulmonary hypertension
• Intubated for status asthmaticus
• Obstructive airway disease (e.g., Severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 <0.30 and/or evidence of increased resistance visible on the flow - time scalar and/or presence of intrinsic PEEP)
• Active air leak
• Bronchiolitis obliterans
• Post hematopoietic stem cell transplant; specifically, patients receiving continuous supplemental oxygen for three or more days prior to intubation; receiving noninvasive ventilation for more than 24 hours prior to intubation; receiving more than one vasoactive medication at time of meeting inclusion criteria; spending more than four days in the PICU prior to intubation; supported on or with immediate plans for renal replacement therapies; with two or more allogeneic transplants; who relapsed after the transplant; or with diffuse alveolar hemorrhage
• Post lung transplant
• Home ventilator dependent with baseline Oxygen Saturation Index (OSI) >6
• Neuromuscular respiratory failure
• Critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
• Facial surgery or trauma in previous 2 weeks
• Head trauma (managed with hyperventilation)
• Intracranial bleeding
• Unstable spine, femur or pelvic fractures
• Open abdomen
• Currently receiving more than 6 consecutive hours of either prone positioning or HFOV
• Supported on ECMO during the current admission
• Family/medical team not providing full support (patient treatment considered futile)
• Previously enrolled in current study

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Banner Health — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Orange County — Orange, California, United States
• Stanford Children's Health — Palo Alto, California, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• University of Iowa Stead Family Chlldren's Hospital — Iowa City, Iowa, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Bloomberg Children's Center, Johns Hopkins University — Baltimore, Maryland, United States
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospital and Medical Center — Omaha, Nebraska, United States
• Cohen Children's Medical Center — Queens, New York, United States
• Duke Children's Hospital — Durham, North Carolina, United States
• UH Rainbow Babies & Children — Cleveland, Ohio, United States
• Children's Hospital at Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States
• Penn State Children's Hospital — Hershey, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Medical City Dallas — Dallas, Texas, United States
• Children's Health Dallas — Dallas, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Children's Hospital of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.