Neola Medical Inc
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…
Lung monitoring with the Neola device
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