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

Launched by XENIOS AG · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the MiniLung petite kit, which is designed to help newborns and young children who are experiencing severe breathing and heart problems. The main goal of the trial is to see if using this kit is safe and if it improves the way the body exchanges gases, like oxygen and carbon dioxide, within the first 24 hours of treatment. By doing this, the researchers hope to keep these young patients stable and healthy while they receive care.

To be eligible for the study, participants need to be between 2 and 8 kilograms in weight and have a serious respiratory or heart issue that requires a special treatment called ECMO (a method that helps support the heart and lungs). Parents or legal guardians will need to give their consent for their child to participate. It’s important to note that children who were born prematurely, have certain allergies, or are currently involved in another clinical study may not be able to take part in this trial. If eligible, participants will be closely monitored while receiving this new treatment, and the healthcare team will provide support throughout the process.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 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
• Exclusion criteria:
• • 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)
• • Impossibility of systemic anticoagulation