Lung Diseases, Preterm Birth, RDS of Prematurity
Conditions
Keywords
GASMAS, Spectroscopy, Gas absorption spectroscopy
Brief summary
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
Detailed description
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.
Interventions
DEVICELung monitoring with the Neola device
Lung monitoring with the Neola device
Sponsors
Neola Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 44 Weeks
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of device related events including skin reactions | 2 days | The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events. Outcome measure: The number of device related events including skin reactions. |
| The number of serious and non-serious adverse events occurring during the trial | 2 days | The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events. Outcome measure: The number of serious and non-serious adverse events occurring during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping | 7 days | This endpoint will be presented as the percentage of the total resting/sleeping time that the device is able to measure the clinical parameters relative lung volume and absolute oxygen concentration. |
| The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates | 7 days | This endpoint will be presented as the percentage of the total handling time that the device is able to measure the clinical parameters relative lung volume and absolute oxygen concentration. |
| The adhesive performance of the probes in terms of ability to be repositioned and stay attached | 7 days | The adhesive performance of the probes in terms of ability to be repositioned and stay attached. This exploratory endpoint will be evaluated the percentage of probe adhesives that were able to stay attached for the duration of the measurement session |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the correlation between Neola® measured clinical data and clinical data available from other monitoring devices, procedures or tests. | 7 days | The endpoint will be valuated using diagnostic methods such as, but not limited to: peripheral oxygen saturation (SpO2), x-ray images, Blood gas analysis data (partial pressure of oxygen (PaO2) and carbon dioxide (PaCO2)), respiratory support settings, respiratory rate, heart rate, blood pressure. |
Countries
United States
Contacts
Primary ContactMagnus Johnsson, MSc.
Outcome results
None listed