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ACTIVE NOT RECRUITING

NCT03896763

PROSpect: Prone and Oscillation Pediatric Clinical Trial

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

2 Weeks - 20 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2019-05-01

Completion Date

2027-01-31

Last Updated

2026-02-27

Healthy Volunteers

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.

Inclusion criteria: 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. Exclusion criteria: * 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 * Enrolled in any other interventional clinical trial not approved for co-enrollment * Known pregnancy

Locations (49)

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

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

American Family Children's Hospital, University of Wisconsin

Madison, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Hospital de Pediatría J. P. Garrahan. SAMIC

Buenos Aires, Buenos Aires F.D., Argentina

Perth Children's Hospital

Perth, Western Australia, Australia

Children's Hospital at Westmead

Sydney, Australia

Sabara Hospital Infantil

São Paulo, Brazil, Brazil

Hospital SEPACO

São Paulo, Brazil

Centre Hospitalier Universitaire Sainte Justine

Montreal, Quebec, Canada

Münster University Hospital

Münster, Germany

Rainbow Children's Hospital

Hyderabad, India

Hadassah Medical Center

Jerusalem, Israel

Meyer Children's Hospital

Florence, Italy, Italy

Bambino Gesu Children's Hospital (Area Rossa Unit)

Rome, Italy, Italy

Instituto Giannina Gasilini

Genova, Italy

University of Malaysia Medical Center

Kuala Lumpur, Malaysia

University Medical Center Groningen

Groningen, Netherlands

Chonnam National University Hospital

Gwangju, South Korea

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand

Faculty of Medicine Ramathibodi Hospital

Bangkok, Thailand

Shaikh Khalifa Medical City

Abu Dhabi, United Arab Emirates

Birmingham Children's Hospital

Birmingham, UK, United Kingdom

University Hospital Leicester NHS Trust

Leicester, United Kingdom

Clinical Research Directory

PROSpect: Prone and Oscillation Pediatric Clinical Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (49)