MedPath

Prone and Oscillation Pediatric Clinical Trial

Phase 4
Recruiting
Conditions
Paediatric acute respiratory distress syndrome
10038716
Registration Number
NL-OMON48534
Lead Sponsor
ational Heart, Lung and Blood Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
36
Inclusion Criteria

Pediatric patients >=2 weeks of age (>=42 weeks post gestational age) and <18 years of age*Intubated and mechanically ventilated with severe PARDS for <48 hours per PALICC guidelines(chest imaging consistent with acute pulmonary parenchymal disease and OI >=16 or OSI >=12.3). We require two consecutive blood gases meeting severe PARDS criteria (separated by at least 4 hours during which time the clinical team is working to recruit lung volume and optimize the patient*s hemodynamic status per PALICC guidelines).

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
Status asthmaticus
Obstructive airway disease (e.g.,bronchiolitis or disease states characterized by either: hypercapnia with FiO2< 0.30, and/or evidence of increased resistance visible on the flow -time scalar, and/or presence of intrinsicPEEP)*Bronchiolitis obliterans
Post Hematopoietic Stem Cell transplant
Post lung transplant
Home ventilator (including noninvasive) or home oxygen dependent
Neuromuscular respiratory failure
Critical airway (e.g., post laryngotracheal surgeryor new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
Facial surgeryor trauma in previous 15 days
Headtrauma, intracranial bleeding
Unstable spine, femur or pelvic fractures
Acute abdominal process
Obesity (2w-2y: weight-for-height z-score >+3 WHO; >2y BMI z score >+2 WHO)
Received either prone positioning or HFOV with current illness, supported on ECMO
Previously enrolled in current study
Family/medical team not providingfull support (patient treatment considered futile)
Enrolled in any other critical care interventional clinical trial concurrently
Known pregnancy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Number of 28-ventilator free days</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Non-pulmonary organ dysfunction<br /><br>Interaction between effects body positioning and ventilator mode<br /><br>90-day in-hospital mortality<br /><br>Duration of mechanical ventilation<br /><br>Length of PICU stay</p><br>
© Copyright 2025. All Rights Reserved by MedPath