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

Not yet recruiting

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

• Registration Number: NCT06750536
• Lead Sponsor: Xenios AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-02
• Primary Completion: 2026-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygenation Index	Baseline and during the intervention every 24 hours until a maximum of 29 days	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.

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stabilization	Baseline and during the intervention every 24 hours until a maximum of 29 days	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 secondary endpoint (Hemodynamic stabilization) 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 secondary outcome of Hemodynamic stabilization.
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	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 secondary endpoint (Lung-protective ventilation) 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 secondary outcome of lung-protective ventilation.
Assessment of the frequency of complications	Baseline and during the intervention every 24 hours until a maximum of 29 days	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 secondary endpoint (Frequency of complications) 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 secondary outcome of frequency of complications.

Trial Locations

Locations (1)

Universitätsklinkum Bonn; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany