Clinical trial NCT06750536: Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Official title: Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Alcedis GmbH
First posted: 2024-12-27
Enrollment: 20
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.

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.


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

Primary outcomes:
measure: Oxygenation Index
timeFrame: Baseline and during the intervention every 24 hours until a maximum of 29 days
Secondary outcomes:
measure: Hemodynamic stabilization
timeFrame: Baseline and during the intervention every 24 hours until a maximum of 29 days
measure: Facilitate lung-protective ventilation in patients additionally receiving invasive mechanical ventilation
timeFrame: Baseline and during the intervention every 24 hours until a maximum of 29 days
measure: Assessment of the frequency of complications
timeFrame: Baseline and during the intervention every 24 hours until a maximum of 29 days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinkum Bonn
state: Nordrhein-Westfalen
Study officials:
affiliation: University Hospital, Bonn
name: Andreas Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: