Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial

Launched by MEDICAL UNIVERSITY OF VIENNA · Aug 4, 2021

Keywords

ClinConnect Summary

The Prone Trial is a study looking at whether positioning infants with severe breathing difficulties (known as acute respiratory distress syndrome or ARDS) on their stomachs (prone position) can improve their oxygen levels compared to lying on their backs (supine position). This is particularly important for babies who are on mechanical ventilation, which means they need help breathing. The researchers will measure how well the infants are getting oxygen and use special imaging techniques to see how their lungs are functioning after they receive a treatment called surfactant, which helps keep the lungs open.

To be eligible for this trial, infants must be between 36 weeks and 24 months old, hospitalized in a Pediatric or Neonatal Intensive Care Unit, and need to be on a ventilator for at least 6 hours with a plan to continue for at least another 12 hours. They should show signs of severe ARDS, like difficulty breathing and a specific oxygen measurement. Parents must give written consent for their child to participate. If selected, families can expect close monitoring of their child's breathing and lung function during the study. It's important to note that not all infants with breathing issues will qualify, as there are certain medical conditions that could prevent participation for safety reasons.

Gender

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Eligibility criteria

• 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