Safety and Performance Study of the MiniLung Petite Kit for Neonatal and Pediatric Patients with Severe Respiratory or Cardiac Failure

What this Trial Is About

Researchers are evaluating the safety and performance of the MiniLung petite kit combined with the Xenios console in newborn and young pediatric patients suffering from severe acute respiratory and cardiac failure. This observational study aims to determine if using veno-venous VV and veno-arterial VA Extracorporeal Membrane Oxygenation ECMO with this device is safe and helps improve oxygen and carbon dioxide exchange as well as stabilize heart and lung function within 24 hours compared to treatment before ECMO initiation. The study involves treating eligible neonatal and pediatric patients weighing between 2 and 8 kilograms who require ECMO due to severe respiratory or cardiopulmonary failure. The MiniLung petite kit and Xenios console will be used according to their intended purpose and local clinical standards. Treatment and monitoring will continue for up to 29 days during which various safety and performance outcomes will be assessed. Participants will be closely observed with repeated measurements of oxygenation index, hemodynamic stability, and lung-protective ventilation effectiveness every 24 hours during the intervention period. The frequency of complications will also be recorded to evaluate safety. Parents or legal representatives will provide consent, and the total monitoring duration may last up to 29 days to gather comprehensive data on treatment impact and safety.

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure