Menu
Recruiting NCT06750536

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MiniLung petite kit combined with the Xenios console.
Who it may be relevant to
Registry conditions: Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury. Basic parameters: up to 8 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Oxygenation Index [Time frame: Baseline and during the intervention every 24 hours until a maximum of 29 days]
Secondary outcome measures (3)
  • Hemodynamic stabilization [Time frame: 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 [Time frame: Baseline and during the intervention every 24 hours until a maximum of 29 days]
  • Assessment of the frequency of complications [Time frame: Baseline and during the intervention every 24 hours until a maximum of 29 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 2 centers
  • Universitätsklinkum Bonn — Bonn
  • Universitätsklinikum Mannheim — Mannheim

Identifiers

NCT: NCT06750536 · PMCF-MLP-01-EU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗