MiniLung petite kit for neonates and infants with severe respiratory or cardiac failure
Official title: Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Run by Fresenius Medical Care Deutschland GmbH · NCT06750536 · Data updated 2026-11-12
We will test whether the MiniLung petite kit with the Xenios console safely improves oxygenation, removes CO2, and stabilizes circulation in newborns and young infants (2–8 kg) with severe respiratory or cardiopulmonary failure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 8 Months |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fresenius Medical Care Deutschland GmbH Industry-sponsored |
| Locations | 2 sites (Bonn, North Rhine-Westphalia and 1 other locations) |
| Status | Recruiting |
| Started | October 12, 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | December 24, 2025 |
| Trial ID | NCT06750536 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Newborns and young pediatric patients weighing 2–8 kg who have acute severe respiratory and/or cardiopulmonary failure requiring VV or VA ECMO and whose parent or legal representative provides informed consent.
✕Probably not a fit
Patients born before 34 weeks' gestation, those with hypersensitivity to heparin or known heparin-induced thrombocytopenia, those who cannot receive systemic anticoagulation, or patients outside the 2–8 kg range are unlikely to benefit from this device in the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational device evaluation of the MiniLung petite kit used with the Xenios console in neonatal and pediatric patients requiring veno-venous or veno-arterial ECMO. The study compares gas exchange (oxygenation and CO2 removal) and hemodynamic status within 24 hours after ECMO initiation to values before ECMO. Eligible patients are those weighing 2–8 kg with acute severe respiratory and/or cardiopulmonary failure and an ECMO indication, with parental consent. The trial is non-randomized and will be conducted at participating university hospitals in Germany.
Why it matters
Potential benefit: If successful, the MiniLung petite kit could offer a safer, size-appropriate ECMO option that more quickly improves oxygenation and hemodynamic support in very small neonates and infants.
How similar studies have gone: ECMO as a technique for neonatal and pediatric respiratory or cardiac support has established benefit, and smaller neonatal-specific ECMO circuits have been used before, but prospective device-specific data on the MiniLung petite kit are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Universitätsklinkum Bonn
Bonn, North Rhine-Westphalia, Germany Recruiting -
Universitätsklinikum Mannheim
Mannheim, Germany Recruiting
Study contacts
- Principal investigator: Andreas Müller, Prof. Dr. — University Hospital, Bonn
- Study coordinator: Anja Derlet-Savoia
- Email: Anja.Derlet@freseniusmedicalcare.com
- Phone: +49 6172 268 6648
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.