An interventional study of Prone positioning in Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction and Infant, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.
The acute respiratory distress syndrome (ARDS) is an acute lung injury that can be triggered by pulmonary (direct lung injury) and extrapulmonary (indirect lung injury) etiologies. Pediatric ARDS (pARDS) occurs in approximately 3% of children admitted to intensive care units (ICUs) and is associated with approximately 17% mortality. The primary etiologies of pARDS have been summarized as pneumonia (35%), aspiration (15%), sepsis (13%), near-drowning (9%), cardiac disease (7%), and other clinical conditions (21%). ARDS manifests as pulmonary inflammation, alveolar edema, and hypoxemic respiratory failure. Mechanical ventilation remains an essential component in the care of patients with ARDS. Many adjunctive treatments rely on pathophysiological considerations. The pathophysiology of ARDS is characterized by inflammatory, proliferative, and fibrotic phases. The different phases induce a ventilation-perfusion mismatch. Inflammation causes surfactant inactivation and depletion. A number of clinical studies have reported clinical benefits following the instillation of exogenous surfactant in pediatric patients with acute respiratory failure. On the other side, prone positioning seem to be a promising intervention in critically ill infants and children with infection-associated acute lung injury. However, data conflict on the use of prone positioning in pediatric patients with acute lung injury.
Turning patients with moderate to severe lung disease into prone position has shown many positive effects. Prolonged intervals of prone positioning have been associated with a decrease in mortality in adult patients with acute respiratory failure. An increase in partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) has been described after 4 hours in prone position in adult patients with severe acute respiratory failure. Similarly, a decrease of the oxygenation index has been found after 8 hours of prone positioning in adult patients with respiratory failure from coronavirus disease of 2019 (COVID-19) associated acute respiratory distress syndrome. The process of prone positioning appeared safe also in critically ill infants and children. In a randomized control trial, it has been shown that in 90% of prone positioning oxygenation index decreased of more than 10% in children with acute lung injury.
Electrical impedance tomography (EIT) and lung ultrasound (LUS) are two non-invasive methods to monitor aeration and lung function parameters. EIT can quantify regional distribution of ventilation as well as improvement in end-expiratory air content. EIT has been used at bedside in critically ill adult patients to measure effects of prone position and also in infants with respiratory distress syndrome. On the other side, LUS has become an increasingly popular diagnostic bedside tool for lung examination. It is considered reliable and fast to detect various lung-related pathologies, such as pneumonia, atelectasis, pneumothorax, and interstitial syndrome.
The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. To accomplish this, oxygenation parameters and measurements from EIT and LUS will be compared in mechanically ventilated infants in prone position versus supine position after surfactant administration.
989 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.
This study's planned enrollment of 14 is below the median of 54 across 561 interventional studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical context
Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68):
Other non-inclusion criteria
Turn patient in prone position after surfactant administration. After 6 hours turn patient in supine position and perform EIT and LUS.
Other: Prone positioning
Leave patient in supine position after surfactant administration. After 6 hours perform EIT and LUS.
Turn patient in prone position after surfactant administration.
Change in Oxygenation saturation index
Oxygenation saturation index (OSI) defined by \[FiO2 x mean airway pressure x 100\]/Peripheral oxygen saturation (SpO2) in millibar \[mbar\] (wean FiO2 to maintain SpO2 ≤ 97% to calculate OSI). OSI values will be calculated after a stable value of SpO2 and mean airway pressure (MAP) will be reached (see ventilation management). The OSI gradient will be calculated as follows: 100\*((OSI (0) - OSI (6h)) / OSI (0) = change of OSI in %. OSI (0) accounts for the OSI prior to the prone position (intervention) and OSI (6h) accounts for the OSI six hours after the intervention.
Time frame: Change from baseline oxygenation saturation index at 6 hours
Chang in Lung Ultrasound
Each lung (left and right) is divided into 6 areas (upper anterior, lower anterior, upper lateral, lower lateral, upper posterior, lower posterior). The Lung Ultrasound Score is assigned as follows: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations. The total LUS score ranges from 0 (best) to 36.
Time frame: Change from baseline LUS score at 6 hours
Change in the Distribution of the End-Expiratory Lung Volume
End-expiratory lung impedance (EELV) is the average of the measured impedance at the end of expiration \[arbitrary units\].
Time frame: Change from baseline EELV at 6 hours
Change in the Distribution of the Tidal Volume
Tidal volume is the average difference of end-inspiratory and end-expiratory impedance measurements \[arbitrary units\].
Time frame: Change from baseline tidal volume at 6 hours
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Vienna