NCT06750536Recruiting
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- 12 Oct 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Xenios AG
- Diseases
- Heart failure
- NCT number
- NCT06750536
What you commit to
- Study type: Observational
- Planned participants: 20
- From 12 Oct 2025 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy
- Previous participation in the same study
Other illness
- Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT)
Age
- Prematurity (\<34 weeks gestational age)
Other
- Impossibility of systemic anticoagulation
Who the study is looking for
- 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
Age in the registry: - to 8 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinkum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitätsklinikum Mannheim Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.