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

This study is evaluating the safety and performance of a specialized heart-lung bypass device called the MiniLung Petite Kit in newborns and small children who are experiencing severe breathing or heart failure and need extracorporeal life support (ECMO — a machine that takes over the work of the heart and lungs temporarily). **You may be eligible if...** - You are a newborn or young child weighing between 2 and 8 kilograms - You need ECMO (heart-lung bypass machine support) due to severe acute breathing and/or heart failure - A parent or legal guardian has signed the informed consent **You may NOT be eligible if...** - The child was born prematurely (before 34 weeks of pregnancy) - The child has a known allergy to heparin or a condition called heparin-induced thrombocytopenia (HIT) - The child cannot receive blood-thinning medication - The child has participated in another clinical study in the past 30 days that could interfere with this treatment Talk to your doctor to see if this trial is right for you.