Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Preterm Birth; RDS of Prematurity
• Intervention / Treatment: Device: Monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Sweden
    • Borås, Sweden, Sweden, 501 82
      • Södra Älvsborgs Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Device: Monitoring; Lung monitoring with the Neola device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 days
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.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping	This exploratory 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.	2 hours
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates	This exploratory 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.	2 hours
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.	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The gas absorption is measured as %m, which is the gas concentration in % (partial pressure / total pressure) multiplied by absorption path length in meter (m). The signal to noise is measured as a ratio without any unit.	2 hours
Influence of ambient light on the gas absorption signals	This will be evaluated as how much ambient light contributes to the gas absorption signal, measured in the units %m. This will be evaluated by comparing gas absorption signals when ambient light is blocked versus not blocked. The gas absorption is measured as %m, which is the gas concentration in % (partial pressure / total pressure) multiplied by absorption path length in meter (m).	2 hours
Influence of emitted light scattered out in the surrounding room that is detected by the detector probe	This will be evaluated by assessing how much scattered light contributes to the gas absorption signal which is measured in the units %m. This will be evaluated by comparing gas absorption signals when scattered light is blocked versus not blocked. The gas absorption is measured as %m, which is the gas concentration in % (partial pressure / total pressure) multiplied by absorption path length in meter (m).	2 hours

Collaborators and Investigators

• Sponsor: Neola Medical AB
• Investigators: Principal Investigator: Gustaf Lernfelt, Södra Älvsborgs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Spectroscopy; GASMAS; Gas absorption spectroscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Premature Birth; Lung Diseases; Respiratory Distress Syndrome In Premature Infants
• Other Study ID Numbers: PLN-0654; CIV-24-05-047374 (Other Identifier: Swedish Medical Products Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No