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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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Universitätsklinkum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Start Date
October 12, 2025
Primary Completion Date
October 1, 2026
Completion Date
December 1, 2026
Last Updated
December 24, 2025
20
ESTIMATED participants
MiniLung petite kit combined with the Xenios console
DEVICE
Lead Sponsor
Xenios AG
Collaborators
NCT05440851
NCT05423301
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05830721