Clinical trial NCT06917326: Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Official title: Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: RDS of Prematurity
Preterm Birth
Lung Diseases
Keywords: GASMAS
Spectroscopy
Gas absorption spectroscopy
Lead sponsor: Neola Medical AB
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Clinical pilot 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 on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of serious and non-serious adverse events occurring during the trial
timeFrame: 2 days
measure: The number of device related events including skin reactions
timeFrame: 2 days
Secondary outcomes:
measure: The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping
timeFrame: 2 hours
measure: The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
timeFrame: 2 hours
measure: The adhesive performance of the probes in terms of ability to be repositioned and stay attached
timeFrame: 2 hours
Other outcomes:
measure: The gas absorption signals and noise at five different pre-determined locations of emitter and detector probe positions for the left and right side of the body
timeFrame: 2 hours
measure: Influence of ambient light on the gas absorption signals
timeFrame: 2 hours
measure: Influence of emitted light scattered out in the surrounding room that is detected by the detector probe
timeFrame: 2 hours
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborgs Sjukhus
Study officials:
affiliation: Sodra Alvsborgs Hospital
name: Gustaf Lernfelt
role: PRINCIPAL_INVESTIGATOR
References: