Prone positioning for infants with severe respiratory distress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the short-term effects of placing infants with severe acute respiratory distress syndrome (ARDS) in a prone position compared to a supine position after surfactant administration. It will measure oxygenation parameters and utilize electrical impedance tomography (EIT) and lung ultrasonography (LUS) to assess lung function in mechanically ventilated infants. The research focuses on infants hospitalized in the Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) at the Medical University of Vienna. The goal is to determine if prone positioning can improve outcomes in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Medical University of Vienna
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Tobias Werther — Medical University of Vienna
• Study coordinator: Tobias Werther
• Email: tobias.werther@meduniwien.ac.at
• Phone: +4314040032320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.