Actively Recruiting
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Led by Xenios AG · Updated on 2025-12-24
20
Participants Needed
2
Research Sites
59 weeks
Total Duration
On this page
Sponsors
X
Xenios AG
Lead Sponsor
A
Alcedis GmbH
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parents or legal representative and investigator
- Bodyweight between 2 and 8 kg
- Acute severe respiratory and/or cardiopulmonary failure with ECMO indication
You will not qualify if you...
- Participation in another interventional clinical study in the past 30 days that could interfere with ECMO therapy
- Previous participation in this same study
- Premature birth before 34 weeks gestational age
- Allergy to heparin or history of heparin-induced thrombocytopenia
- Inability to receive systemic anticoagulation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Universitätsklinkum Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
2
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
Research Team
A
Anja Derlet-Savoia
CONTACT
L
Lena Wachter
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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