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| Name | Class |
|---|---|
| Alcedis GmbH | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniLung petite kit combined with the Xenios console | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and during the intervention every 24 hours until a maximum of 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria
Exclusion criteria:
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Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Derlet-Savoia | Contact | +49 6172 268 6648 | Anja.Derlet@freseniusmedicalcare.com | |
| Lena Wachter | Contact | Lena.Wachter@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Müller, Prof. Dr. | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinkum Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
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| Baseline and during the intervention every 24 hours until a maximum of 29 days |
| 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. | Baseline and during the intervention every 24 hours until a maximum of 29 days |
| 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. | Baseline and during the intervention every 24 hours until a maximum of 29 days |
| Universitätsklinikum Mannheim | Recruiting | Mannheim | 68167 | Germany |
|
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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