Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prone positioning
Treatment groups
14 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov