MiniLung petite kit for neonates and infants with severe respiratory or cardiac failure
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | N/A to 8 Months |
| Sex | All |
| Sponsor | Fresenius Medical Care Deutschland GmbH Industry-sponsored |
| Locations | 2 sites (Bonn, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT06750536 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bonn, North Rhine-Westphalia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.