PROSpect: Prone and Oscillation Pediatric Clinical Trial

  • STATUS
    Recruiting
  • End date
    May 25, 2024
  • participants needed
    1000
  • sponsor
    University of Pennsylvania
Updated on 25 January 2021

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 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).

Description

PROSpect is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and conventional mechanical ventilation (CMV)/high-frequency oscillatory ventilation (HFOV). About 45 pediatric intensive care units (PICUs), 30 U.S. and 15 international, with at least 5 years of experience with prone positioning and HFOV in the care of pediatric patients with severe Pediatric Acute Respiratory Distress Syndrome (PARDS), that can provide back-up extracorporeal membrane oxygenation (ECMO) support, are participating. Eligible consecutive subjects with severe PARDS will be randomized 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) through day 28, where non-survivors receive zero VFD. We hypothesize that children with severe PARDS treated with either prone positioning or HFOV will demonstrate 2 more VFD. 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, stratified by age group and direct/indirect lung injury. Adaptive randomization will first occur after 400 patients are randomized and have been followed for 28 days, and every 100 patients thereafter. At these randomization update analyses, new allocation probabilities will be computed based on ongoing 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 received for primary, secondary and exploratory analyses.

Details
Condition Acute Respiratory Distress Syndrome in Children
Treatment Either supine or prone positioning and either CMV or HFOV
Clinical Study IdentifierNCT03896763
SponsorUniversity of Pennsylvania
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 18 yrs?
Gender: Male or Female
Do you have Acute Respiratory Distress Syndrome in Children?
Do you have any of these conditions: Do you have Acute Respiratory Distress Syndrome in Children??
Intubated and mechanically ventilated with 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
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 (including noninvasive) or home oxygen dependent (exception: night-time noninvasive ventilation (CPAP/BiPAP) or oxygen for obstructive sleep apnea is permitted)
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
Acute abdominal process/open abdomen
Morbid obesity (2w-24 months: WHO weight-for-length/height z-score +3; 2 years: WHO body mass index (BMI)-for-age z-score +3)
Currently receiving either prone positioning or any high-frequency mode of MV with current illness (Up to 4 hours of prone positioning and/or any mode of high-frequency mode of MV is allowed as long as the therapies are off for least 4 hours prior to the subject meeting oxygenation criteria.)
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
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