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.
Informed consent signed and dated by parents or legal representative and investigator/authorized physician
Patients ≥2- ≤8 kg bodyweight to be treated with the MiniLung petite kit
Acute severe respiratory and/or cardiopulmonary failure with an ECMO indication
Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy
Previous participation in the same study
Prematurity (<34 weeks gestational age)
Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT)
Xenios AG
Lead sponsor
Alcedis GmbH
Collaborator