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

NCT06750536 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-12-24

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Alcedis GmbH

    collaborator INDUSTRY

  • Xenios AG

    lead INDUSTRY

Principal Investigators

  • Andreas Müller, Prof. Dr. · University Hospital, Bonn

Eligibility

Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-12
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750536 on ClinicalTrials.gov