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

NCT06917326 | Completed

• 2 other identifiers: PLN-0654CIV-24-05-047374
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Birth; Lung Diseases; RDS of Prematurity

Keywords

GASMAS; Spectroscopy; Gas absorption spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping

  2 hours

• The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates

  2 hours

• The adhesive performance of the probes in terms of ability to be repositioned and stay attached

  2 hours

Other Outcomes (3)

• 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

  2 hours

• Influence of ambient light on the gas absorption signals

  2 hours

• Influence of emitted light scattered out in the surrounding room that is detected by the detector probe

  2 hours

Study Arms (1)

Arm 1

EXPERIMENTAL

Device: Monitoring

Interventions

Monitoring DEVICE

Lung monitoring with the Neola device

Arm 1

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neola Medical AB: lead

Study Sites (1)

Södra Älvsborgs Sjukhus

Borås, Sweden, 501 82, Sweden

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Premature Birth; Lung Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Diseases

Study Officials

• Gustaf Lernfelt

  Sodra Alvsborgs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 8, 2025
• Study Start: May 20, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)