MiniLung petite kit combined with the Xenios console
MiniLung petite kit combined with the Xenios console: Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) treatment will be performed using the MiniLung petite kit combined with the Xenios console according to their intended use and local standards/requirements.
Study 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
Sex
ALL
Min age
—
Max age
8 Months
Healthy volunteers
No
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
Primary outcome measure(s)
Oxygenation Index — Baseline and during the intervention every 24 hours until a maximum of 29 days Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint (Oxygenation Index) as a covariate.
Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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