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

NCT06750536 | Recruiting

• 1 other identifier: PMCF-MLP-01-EU
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Extracorporeal Membrane Oxygenation; Neonatal and pediatric patients; MiniLung petite kit

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index

  Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint (Oxygenation Index) as a covariate. Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.

  Baseline and during the intervention every 24 hours until a maximum of 29 days

Secondary Outcomes (3)

• Hemodynamic stabilization

  Baseline and during the intervention every 24 hours until a maximum of 29 days

• Facilitate lung-protective ventilation in patients additionally receiving invasive mechanical ventilation

  Baseline and during the intervention every 24 hours until a maximum of 29 days

• Assessment of the frequency of complications

  Baseline and during the intervention every 24 hours until a maximum of 29 days

Interventions

MiniLung petite kit combined with the Xenios console DEVICE

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.

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xenios AG: lead
• Alcedis GmbH: collaborator

Study Sites (2)

Universitätsklinkum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andreas Müller, Prof. Dr.

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Derlet-Savoia

CONTACT

+49 6172 268 6648; Anja.Derlet@freseniusmedicalcare.com

Lena Wachter

CONTACT

Lena.Wachter@freseniusmedicalcare.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 27, 2024
• Study Start: October 12, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

DE (2)