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.
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
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)
Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.
Other
Prospective
MiniLung petite kit combined with the Xenios console
DeviceVeno-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.
Oxygenation Index
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.
Hemodynamic stabilization
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 secondary endpoint (Hemodynamic stabilization) 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 secondary outcome of Hemodynamic stabilization.
Facilitate lung-protective ventilation in patients additionally receiving invasive mechanical ventilation
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 secondary endpoint (Lung-protective ventilation) 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 secondary outcome of lung-protective ventilation.
Assessment of the frequency of complications
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 secondary endpoint (Frequency of complications) 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 secondary outcome of frequency of complications.
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Xenios AG
Lead sponsor
Alcedis GmbH
Collaborator
