Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

RECRUITING

NCT06750536

Sponsor: Xenios AG

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.

Key Details

Gender

All

Age Range

Any - 8 Months

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-10-12

Completion Date

2026-12

Last Updated

2025-12-24

Healthy Volunteers

No

Conditions

Extracorporeal Membrane Oxygenation Complication Neonatal Aspiration Pneumonia Acute Respiratory Failure Acute Lung Injury

Interventions

DEVICE

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.

Locations (2)

Universitätsklinkum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

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