Multicenter, randomized, controlled study of porcine surfactant in severe respiratory syncytial virus-induced respiratory failure.
Marco Luchetti, Federica Ferrero, Carla Gallini...
https://pubmed.ncbi.nlm.nih.gov/12780967/Actively Recruiting
Led by Medical University of Vienna · Updated on 2026-08-06
14
Participants Needed
1
Research Sites
21 weeks
Total Duration
This research investigates the short-term effects of prone positioning on infants with infection-associated severe acute respiratory distress syndrome ARDS. The study focuses on infants who are mechanically ventilated and have received surfactant treatment. The main goal is to compare oxygenation parameters and lung function using electrical impedance tomography EIT and lung ultrasonography LUS between infants placed in prone versus supine positions. Participants are randomly assigned to one of two groups one group is turned to the prone position immediately after surfactant administration, staying prone for 6 hours before returning to supine for assessment the other group remains in the supine position throughout. Both groups undergo EIT and LUS measurements after 6 hours to evaluate lung aeration and function. During the study, infants are monitored for changes in oxygenation saturation index and lung ultrasound scores from baseline to 6 hours post-intervention. Researchers also assess the distribution of end-expiratory lung volume and tidal volume using EIT. Parental consent is required, and infants must be intubated and mechanically ventilated. The study is conducted at a pediatric or neonatal intensive care unit and is expected to complete by the end of 2027.
CONDITIONS
Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial
T
Tobias Werther
M
Michael Hermon
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Medical University of Vienna
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 hours
Participants receive surfactant treatment and are assigned to either prone or supine position. After 6 hours, lung function is assessed using electrical impedance tomography and lung ultrasound.
1 visit with monitoring and assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23403804/Medical University of Vienna
Lead Sponsor