Studies a small lung support device in infants and children with severe breathing failure
Observes a small ECMO lung-support kit in newborns and young children.
Plain-language title generated from the registry record
Registry title: Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Key facts
- Where
- Bonn and Mannheim, GermanySee the 2 sites
Where in Germany
- Universitätsklinkum BonnBonn, GermanyTaking people
- Universitätsklinikum MannheimMannheim, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xenios AG
- Trial code
- NCT06750536
- Record updated
- 24 December 2025
- Original description
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.Read full original descriptionShow less
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
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.
Inclusion: 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: Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy; Previous participation in the same study; Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT); Prematurity (<34 weeks gestational age); Impossibility of systemic anticoagulation.