Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial
Recruiting now · Not applicable
Conditions studied: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
In brief
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.
Key facts
- Study ID
- NCT05002478
- Run by
- Medical University of Vienna
- People needed
- 14
- Starts
- 2022-07-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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
Where it is running
- Medical University of Vienna — Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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