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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-12

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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

Keywords

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Extracorporeal Membrane Oxygenation Neonatal and pediatric patients MiniLung petite kit

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Müller, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

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Universitätsklinkum Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anja Derlet-Savoia

Role: CONTACT

Phone: +49 6172 268 6648

Email: [email protected]

Lena Wachter