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

Neola Medical AB10 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

RDS of Prematurity Preterm Birth Lung Diseases

Interventions

MonitoringDEVICE

Lung monitoring with the Neola device

Eligibility

Sex: ALLMin age: 1 DayMax age: 14 Days

Medical Language ↔ Plain English

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.

Locations (1)

Södra Älvsborgs Sjukhus

Borås, Sweden, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 hours

Data from ClinicalTrials.gov

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