Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates (NCT06917326) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Sweden10 participantsStarted 2025-05-20
Plain-language summary
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
Who can participate
Age range1 Day – 14 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
The number of serious and non-serious adverse events occurring during the trial
Timeframe: 2 days
2
The number of device related events including skin reactions