Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

The purpose of the study is to demonstrate that the device is safe and performs as intended under anticipated use conditions.

The performance of Neola will be evaluated in terms of ability to continuously measure and display the relative lung volume and absolute oxygen gas concentration during standard NICU procedures on neonates.

IInclusion criteria:

• Preterm or term born neonates with gestational age between 26 and 40 weeks
• Age between 1 day post-natal and 44 weeks corrected gestational age
• Weight between 1000 g and 3500 g
• Patient treated at a neonatal intensive care unit.
• Patient is either on invasive mechanical ventilation, on CPAP or NIPPV or receives respiratory support via high-flow nasal cannula (≥2L/min)
• Signed informed consent prior to any study related procedures by the legal representatives of the patient

Exclusion criteria

• Known cardiopulmonary congenital anomalies
• Patients with trisomies or other chromosomal abnormality
• Patients not expected to survive
• Non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., Bullous impetigo, Staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus)
• Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.