Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)NCT05002478
Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial
A study testing Prone positioning in people with Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) and Surfactant Dysfunction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
- What is being tested?
- Prone positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jul 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.
- Patients aged >36 weeks (corrected gestational age) and <24 months.
- Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.
- Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and/or findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).
- Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).
- Written informed consent obtained from parents.
Who cannot join
- Clinical context
- Need for O2 supplementation to maintain SpO2>94% in the 4 weeks preceding hospitalization in the PICU/NICU
- Cyanotic congenital heart disease Cardiogenic pulmonary edema
- Severe pulmonary hypertension
- Untreated pneumothorax
- Severe neurological abnormalities
Show all 24Show fewer
- Other severe congenital anomalies such as congenital diaphragmatic hernia
- Ongoing cardiopulmonary resuscitation or limitation of life support
- 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):
- Intracranial pressure >30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure <60 mmHg
- Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
- Tracheal surgery or sternotomy during the previous 15 days
- Serious facial trauma or facial surgery during the previous 15 days
- Deep venous thrombosis treated for less than 2 days
- Cardiac pacemaker inserted in the last 2 days
- Unstable spine, femur, or pelvic fractures
- Use of extracorporeal membrane oxygenation (ECMO) before inclusion
- Lung transplantation
- Burns on more than 20% of the body surface
- Other non-inclusion criteria
- Indication not to attempt resuscitation
- Patient already recruited for other clinical studies
- Patients who already received surfactant in the last 4 weeks
- Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Tobias Werther, 014040032320, tobias.werther@meduniwien.ac.at
About this study
Official title: Short-Term Effect of Prone Positioning in Infants With Severe Acute Respiratory Distress Syndrome
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.
Read the detailed description
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.
- Conditions
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
- Being tested
- Prone positioning
- Keywords
- Acute Respiratory Distress Syndrome, Electrical Impedance Tomography, Lung Ultrasonography, Prone Position, Infants
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Surfactant Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningOther
Turn patient in prone position after surfactant administration.
| Study group | Role | What they receive |
|---|---|---|
| Prone Group | Experimental | Turn patient in prone position after surfactant administration. After 6 hours turn patient in supine position and perform EIT and LUS. Receives: Other: Prone positioning |
| Supine Group | No intervention | Leave patient in supine position after surfactant administration. After 6 hours perform EIT and LUS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline oxygenation saturation index at 6 hours
Secondary outcomes (3)
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.
Measured: 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].
Measured: 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].
Measured: Change from baseline tidal volume at 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start30 Jul 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center randomized controlled study
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Werther, Medical University of Vienna
- Investigators
- Tobias Werther, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002478
- Sponsor's protocol ID
- 1426/2021
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheifetz IM. Pediatric ARDS. Respir Care. 2017 Jun;62(6):718-731. doi: 10.4187/respcare.05591.
PubMed 28546374Khemani RG, Smith L, Lopez-Fernandez YM, Kwok J, Morzov R, Klein MJ, Yehya N, Willson D, Kneyber MCJ, Lillie J, Fernandez A, Newth CJL, Jouvet P, Thomas NJ; Pediatric Acute Respiratory Distress syndrome Incidence and Epidemiology (PARDIE) Investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study. Lancet Respir Med. 2019 Feb;7(2):115-128. doi: 10.1016/S2213-2600(18)30344-8. Epub 2018 Oct 22.
PubMed 30361119Santschi M, Randolph AG, Rimensberger PC, Jouvet P; Pediatric Acute Lung Injury Mechanical Ventilation Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network; European Society of Pediatric and Neonatal Intensive Care. Mechanical ventilation strategies in children with acute lung injury: a survey on stated practice pattern*. Pediatr Crit Care Med. 2013 Sep;14(7):e332-7. doi: 10.1097/PCC.0b013e31828a89a2.
PubMed 23842587Orloff KE, Turner DA, Rehder KJ. The Current State of Pediatric Acute Respiratory Distress Syndrome. Pediatr Allergy Immunol Pulmonol. 2019 Jun 1;32(2):35-44. doi: 10.1089/ped.2019.0999. Epub 2019 Jun 17.
PubMed 31236307Mok YH, Lee JH, Rehder KJ, Turner DA. Adjunctive treatments in pediatric acute respiratory distress syndrome. Expert Rev Respir Med. 2014 Dec;8(6):703-16. doi: 10.1586/17476348.2014.948854. Epub 2014 Aug 13.
PubMed 25119574Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
PubMed 24134414De Luca D, Cogo P, Kneyber MC, Biban P, Semple MG, Perez-Gil J, Conti G, Tissieres P, Rimensberger PC. Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps. Crit Care. 2021 Feb 22;25(1):75. doi: 10.1186/s13054-021-03489-6.
PubMed 33618742Amigoni A, Pettenazzo A, Stritoni V, Circelli M. Erratum to: Surfactants in Acute Respiratory Distress Syndrome in Infants and Children: Past, Present and Future. Clin Drug Investig. 2017 Jul;37(7):711. doi: 10.1007/s40261-017-0544-x. No abstract available.
PubMed 28589372Luchetti M, Ferrero F, Gallini C, Natale A, Pigna A, Tortorolo L, Marraro G. Multicenter, randomized, controlled study of porcine surfactant in severe respiratory syncytial virus-induced respiratory failure. Pediatr Crit Care Med. 2002 Jul;3(3):261-268. doi: 10.1097/00130478-200207000-00011.
PubMed 12780967Jat KR, Chawla D. Surfactant therapy for bronchiolitis in critically ill infants. Cochrane Database Syst Rev. 2015 Aug 24;2015(8):CD009194. doi: 10.1002/14651858.CD009194.pub3.
PubMed 26299681Willson DF, Thomas NJ, Markovitz BP, Bauman LA, DiCarlo JV, Pon S, Jacobs BR, Jefferson LS, Conaway MR, Egan EA; Pediatric Acute Lung Injury and Sepsis Investigators. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005 Jan 26;293(4):470-6. doi: 10.1001/jama.293.4.470.
PubMed 15671432Ward NS. Effects of prone position ventilation in ARDS. An evidence-based review of the literature. Crit Care Clin. 2002 Jan;18(1):35-44. doi: 10.1016/s0749-0704(03)00063-0.
PubMed 11910731Lupton-Smith A, Argent A, Rimensberger P, Frerichs I, Morrow B. Prone Positioning Improves Ventilation Homogeneity in Children With Acute Respiratory Distress Syndrome. Pediatr Crit Care Med. 2017 May;18(5):e229-e234. doi: 10.1097/PCC.0000000000001145.
PubMed 28328787Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
PubMed 20130832Curley MA, Hibberd PL, Fineman LD, Wypij D, Shih MC, Thompson JE, Grant MJ, Barr FE, Cvijanovich NZ, Sorce L, Luckett PM, Matthay MA, Arnold JH. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13;294(2):229-37. doi: 10.1001/jama.294.2.229.
PubMed 16014597
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effect of Prone Positioning in Infants With Severe Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05002478
- Acronym / sponsor ID
- 1426/2021
- Conditions
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
- Keywords
- Acute Respiratory Distress Syndrome, Electrical Impedance Tomography, Lung Ultrasonography, Prone Position, Infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Prone Group | Experimental | Other: Prone positioningTurn patient in prone position after surfactant administration. After 6 hours turn patient in supine position and perform EIT and LUS. |
| Supine Group | No intervention | –Leave patient in supine position after surfactant administration. After 6 hours perform EIT and LUS. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.
- Patients aged >36 weeks (corrected gestational age) and <24 months.
- Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.
- Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and/or findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).
- Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positioningTurn patient in prone position after surfactant administration. | Other | Prone Group |
Primary outcome
Change in Oxygenation saturation index
Time frame: Change from baseline oxygenation saturation index at 6 hours
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.
3 secondary outcomes
Chang in Lung Ultrasound
Time frame: Change from baseline LUS score at 6 hours
Change in the Distribution of the End-Expiratory Lung Volume
Time frame: Change from baseline EELV at 6 hours
Change in the Distribution of the Tidal Volume
Time frame: Change from baseline tidal volume at 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 28546374Cheifetz IM. Pediatric ARDS. Respir Care. 2017 Jun;62(6):718-731. doi: 10.4187/respcare.05591.
- Background: PubMed 30361119Khemani RG, Smith L, Lopez-Fernandez YM, Kwok J, Morzov R, Klein MJ, Yehya N, Willson D, Kneyber MCJ, Lillie J, Fernandez A, Newth CJL, Jouvet P, Thomas NJ; Pediatric Acute Respiratory Distress syndrome Incidence and Epidemiology (PARDIE) Investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study. Lancet Respir Med. 2019 Feb;7(2):115-128. doi: 10.1016/S2213-2600(18)30344-8. Epub 2018 Oct 22.
- Background: PubMed 23842587Santschi M, Randolph AG, Rimensberger PC, Jouvet P; Pediatric Acute Lung Injury Mechanical Ventilation Investigators; Pediatric Acute Lung Injury and Sepsis Investigators Network; European Society of Pediatric and Neonatal Intensive Care. Mechanical ventilation strategies in children with acute lung injury: a survey on stated practice pattern*. Pediatr Crit Care Med. 2013 Sep;14(7):e332-7. doi: 10.1097/PCC.0b013e31828a89a2.
- Background: PubMed 31236307Orloff KE, Turner DA, Rehder KJ. The Current State of Pediatric Acute Respiratory Distress Syndrome. Pediatr Allergy Immunol Pulmonol. 2019 Jun 1;32(2):35-44. doi: 10.1089/ped.2019.0999. Epub 2019 Jun 17.
- Background: PubMed 25119574Mok YH, Lee JH, Rehder KJ, Turner DA. Adjunctive treatments in pediatric acute respiratory distress syndrome. Expert Rev Respir Med. 2014 Dec;8(6):703-16. doi: 10.1586/17476348.2014.948854. Epub 2014 Aug 13.
- Background: PubMed 24134414Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
- Background: PubMed 33618742De Luca D, Cogo P, Kneyber MC, Biban P, Semple MG, Perez-Gil J, Conti G, Tissieres P, Rimensberger PC. Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps. Crit Care. 2021 Feb 22;25(1):75. doi: 10.1186/s13054-021-03489-6.
- Background: PubMed 28589372Amigoni A, Pettenazzo A, Stritoni V, Circelli M. Erratum to: Surfactants in Acute Respiratory Distress Syndrome in Infants and Children: Past, Present and Future. Clin Drug Investig. 2017 Jul;37(7):711. doi: 10.1007/s40261-017-0544-x. No abstract available.
- Background: PubMed 12780967Luchetti M, Ferrero F, Gallini C, Natale A, Pigna A, Tortorolo L, Marraro G. Multicenter, randomized, controlled study of porcine surfactant in severe respiratory syncytial virus-induced respiratory failure. Pediatr Crit Care Med. 2002 Jul;3(3):261-268. doi: 10.1097/00130478-200207000-00011.
- Background: PubMed 26299681Jat KR, Chawla D. Surfactant therapy for bronchiolitis in critically ill infants. Cochrane Database Syst Rev. 2015 Aug 24;2015(8):CD009194. doi: 10.1002/14651858.CD009194.pub3.
- Background: PubMed 15671432Willson DF, Thomas NJ, Markovitz BP, Bauman LA, DiCarlo JV, Pon S, Jacobs BR, Jefferson LS, Conaway MR, Egan EA; Pediatric Acute Lung Injury and Sepsis Investigators. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005 Jan 26;293(4):470-6. doi: 10.1001/jama.293.4.470.
- Background: PubMed 11910731Ward NS. Effects of prone position ventilation in ARDS. An evidence-based review of the literature. Crit Care Clin. 2002 Jan;18(1):35-44. doi: 10.1016/s0749-0704(03)00063-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Werther principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone positioning in people with Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) and Surfactant Dysfunction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Werther (+4314040032320, tobias.werther@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygenation saturation index (time frame: Change from baseline oxygenation saturation index at 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002478, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.