NCT06750536 Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
| NCT ID | NCT06750536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xenios AG |
| Condition | Extracorporeal Membrane Oxygenation Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-12 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-10-12 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Andreas Müller, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital, Bonn
Frequently Asked Questions
Who can join the NCT06750536 clinical trial?
This trial is open to participants of all sexes, up to 8 Months, studying Extracorporeal Membrane Oxygenation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06750536 currently recruiting?
Yes, NCT06750536 is actively recruiting participants. Contact the research team at Anja.Derlet@freseniusmedicalcare.com for enrollment information.
Where is the NCT06750536 trial being conducted?
This trial is being conducted at Bonn, Germany, Mannheim, Germany.
Who is sponsoring the NCT06750536 clinical trial?
NCT06750536 is sponsored by Xenios AG. The principal investigator is Andreas Müller, Prof. Dr. at University Hospital, Bonn. The trial plans to enroll 20 participants.