Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Recruiting · NCT06750536 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xenios AG
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Universitätsklinikum Mannheim - Mannheim, Germany
- Universitätsklinkum Bonn - Bonn, North Rhine-Westphalia, Germany