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
Qualifiers
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
Treatments tested in this trial
- Lung monitoring with the Neola device
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov