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NCT Number: NCT06750536

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

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.

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Key information

Conditions

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

Age range

Up to 8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinkum Bonn, Bonn, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oxygenation Index

    Time frame: 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 outcomes

  1. Hemodynamic stabilization

    Time frame: 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.

  2. 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

    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.

  3. Assessment of the frequency of complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Derlet-Savoia

CONTACT

[email protected]

+49 6172 268 6648

Lena Wachter

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xenios AG

Industry

Collaborators

  • Alcedis GmbH

Registry information

Acronym: PETIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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