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

Xenios

Status: Enrolling

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

Treatments: Device: MiniLung petite kit combined with the Xenios console

Study type: Observational

Funder types: Industry

Identifiers

NCT06750536

PMCF-MLP-01-EU

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 8 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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