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

ClinicalTrials.gov ID

NCT06750536

Lead Sponsor

Xenios AGINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

20Estimated

Last Update Posted

Dec 24, 2025Actual

Start Date

Oct 12, 2025Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Dec 2026Estimated

Official Title

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

Brief 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.

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

• MiniLung petite kit combined with the Xenios console

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria

• 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

Exclusion criteria:

• 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)
• Impossibility of systemic anticoagulation

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Xenios AGINDUSTRY

Collaborators

Alcedis GmbHINDUSTRY

florian.kipfmueller@umm.de

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