Actively Recruiting

Phase Not Applicable
Age: 0 - 12Months
All Genders
NCT05002478

Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial

Led by Medical University of Vienna · Updated on 2024-11-20

14

Participants Needed

1

Research Sites

230 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial

Who Can Participate

Age: 0 - 12Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is hospitalized at the Pediatric or Neonatal Intensive Care Unit of the Medical University Vienna
  • Patient aged over 36 weeks corrected gestational age and under 24 months
  • Patient is intubated and mechanically ventilated for at least 6 hours with expected invasive ventilation for at least 12 hours
  • Clinical signs strongly suggest acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation, or new infiltrates on chest X-ray)
  • Severe pediatric acute respiratory distress syndrome defined by an oxygen saturation index (OSI) of 12.3 or higher
  • Written informed consent obtained from parents
Not Eligible

You will not qualify if you...

  • Need for oxygen supplementation to maintain SpO2 over 94% in the 4 weeks before hospitalization in PICU/NICU
  • Cyanotic congenital heart disease or 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
  • Intracranial pressure over 30 mmHg in supine position or cerebral perfusion pressure under 60 mmHg
  • Massive hemoptysis requiring urgent surgery or interventional radiology
  • Tracheal surgery or sternotomy in the last 15 days
  • Serious facial trauma or facial surgery in the last 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 covering more than 20% of the body surface
  • Indication not to attempt resuscitation
  • Patient already enrolled in other clinical studies
  • Surfactant administration in the last 4 weeks
  • Thoracic skin lesions or wounds where the EIT electrode belt would be placed

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

T

Tobias Werther

CONTACT

M

Michael Hermon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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