Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-44
SponsorNeola Medical Inc
About this trial
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Lung monitoring with the Neola device
DeviceLung monitoring with the Neola device
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Arm 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of device related events including skin reactions
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.
Time frame
2 days2
The number of serious and non-serious adverse events occurring during the trial
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.
Time frame
2 daysSecondary outcomes
1
The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping
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.
Time frame
7 days2
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
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.
Time frame
7 days3
The adhesive performance of the probes in terms of ability to be repositioned and stay attached
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
Time frame
7 daysOther outcomes
1
Evaluate the correlation between Neola® measured clinical data and clinical data available from other monitoring devices, procedures or tests.
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.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov
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