Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Recruiting now
Conditions studied: Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
In brief
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.
Key facts
- Study ID
- NCT06750536
- Run by
- Xenios AG
- People needed
- 20
- Starts
- 2025-10-12
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-24
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Universitätsklinkum Bonn — Bonn, North Rhine-Westphalia, Germany (enrolling)
- Universitätsklinikum Mannheim — Mannheim, Germany (enrolling)
Full record on ClinicalTrials.gov
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