Condition: Extracorporeal Membrane Oxygenation Complication · Neonatal Aspiration Pneumonia · Acute Respiratory Failure · Sponsor: Xenios AG
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure. The main question it aims to answer is (study hypotheses): Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.
This description comes directly from the study's public registry record.
Anja Derlet-Savoia · +49 6172 268 6648 · Anja.Derlet@freseniusmedicalcare.com
Lena Wachter · Lena.Wachter@freseniusmedicalcare.com
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| Universitätsklinkum Bonn | Bonn, North Rhine-Westphalia, Germany | Recruiting |
| Universitätsklinikum Mannheim | Mannheim, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06750536