Extracorporeal Membrane Oxygenation ComplicationPETITNCT06750536
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
An observational study of Extracorporeal Membrane Oxygenation Complication and Neonatal Aspiration Pneumonia, run by Xenios AG at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 8 months
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure
- What is being tested?
- MiniLung petite kit combined with the Xenios console
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 12 Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lena Wachter contact
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinkum Bonn
Bonn, North Rhine-Westphalia, 53127
Lukas Schröder, Dr. med., lukas.schroeder@ukbonn.de
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
Florian Kipfmüller, Prof.Dr.med., florian.kipfmueller@umm.de
About this study
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
- Being tested
- MiniLung petite kit combined with the Xenios console
- Keywords
- Extracorporeal Membrane Oxygenation, Neonatal and pediatric patients, MiniLung petite kit
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniLung petite kit combined with the Xenios consoleDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and during the intervention every 24 hours until a maximum of 29 days
Secondary outcomes (3)
Hemodynamic stabilization
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.
Measured: 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
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.
Measured: Baseline and during the intervention every 24 hours until a maximum of 29 days
Assessment of the frequency of complications
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.
Measured: Baseline and during the intervention every 24 hours until a maximum of 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start12 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenios AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Müller, Prof. Dr., Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750536
- Sponsor's protocol ID
- PMCF-MLP-01-EU
- Acronym
- PETIT
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
- ClinicalTrials.gov ID
- NCT06750536
- Acronym / sponsor ID
- PETIT / PMCF-MLP-01-EU
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Keywords
- Extracorporeal Membrane Oxygenation, Neonatal and pediatric patients, MiniLung petite kit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xenios AGIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniLung petite kit combined with the Xenios consoleVeno-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. | Device | – |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena Wachter contact
Andreas Müller, Prof. Dr. principal investigator
University Hospital, Bonn
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation Complication and Neonatal Aspiration Pneumonia, run by Xenios AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja Derlet-Savoia (+49 6172 268 6648, Anja.Derlet@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (time frame: Baseline and during the intervention every 24 hours until a maximum of 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.