Clinical pilot 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 on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.

Inclusion criteria:

• Preterm or term born neonates with gestational age between 28 and 40 weeks
• Post-natal age between 1 and 14 days
• Weight between 1000 g and 3000 g
• Signed informed consent prior to any study related procedures by the legal representatives of the patient
• Legal representatives are 18 years or older
• Legal representatives can absorb and understand the content of the informed consent form

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.