Mini lung machine tested on tiniest patients

NCT ID NCT06750536

Recruiting now Disease control Sponsor: Xenios AG Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a small device called the MiniLung petite kit, which helps oxygenate blood and remove carbon dioxide in newborns and children weighing 2 to 8 kilograms who have severe breathing or heart failure. The device works with a console to temporarily take over the work of the lungs and heart. Researchers want to see if it safely improves oxygen levels and stabilizes vital signs within 24 hours. The study will enroll 20 participants and observe their progress.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: MiniLung petite kit (a miniaturized ECMO device used with the Xenios console)
What this could lead to: If successful, this could provide a safe and effective way to support breathing and heart function in very small infants with life-threatening respiratory or cardiac failure.
What could go wrong: This is a small, early observational study with only 20 participants, so results may not apply to all patients. ECMO itself carries risks like bleeding, infection, and blood clots.

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory failure aspiration pneumonia heart failure neonatal aspiration syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE LUNG INJURY ACUTE RESPIRATORY FAILURE EXTRACORPOREAL MEMBRANE OXYGENATION COMPLICATION NEONATAL ASPIRATION PNEUMONIA

Contacts and locations

Locations

Universitätsklinikum Mannheim
RECRUITING

Mannheim, 68167, Germany
Universitätsklinkum Bonn
RECRUITING

Bonn, North Rhine-Westphalia, 53127, Germany

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