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Completed

NCT Number: NCT06917326

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

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Key information

Conditions

RDS of Prematurity Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Respiratory Distress Syndrome In Premature Infants Respiratory Tract Diseases Urogenital Diseases

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborgs Sjukhus

Borås, Sweden, 501 82

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

monitoring

Device

Lung monitoring with the Neola device

Primary outcomes

  1. The number of serious and non-serious adverse events occurring during the trial

    Time frame: 2 days

    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. The number of device related events including skin reactions

    Time frame: 2 days

    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.

Secondary outcomes

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

    Time frame: 2 hours

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

    Time frame: 2 hours

    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.

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

    Time frame: 2 hours

    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.

Other outcomes

  1. 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

    Time frame: 2 hours

    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. Influence of ambient light on the gas absorption signals

    Time frame: 2 hours

    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).

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

    Time frame: 2 hours

    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).

Sponsors and collaborators

Lead sponsor

Neola Medical AB

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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