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

N/ANot Yet RecruitingNCT07060911

Neola Medical Inc22 enrolled

Overview

Pivotal 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 during standard NICU procedures on neonates.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

RDS of Prematurity Preterm Birth Lung Diseases

Interventions

Lung monitoring with the Neola deviceDEVICE

Lung monitoring with the Neola device

Eligibility

Sex: ALLMin age: 1 DayMax age: 44 Weeks

Medical Language ↔ Plain English

IInclusion criteria: * Preterm or term born neonates with gestational age between 26 and 40 weeks * Age between 1 day post-natal and 44 weeks corrected gestational age * Weight between 1000 g and 3500 g * Patient treated at a neonatal intensive care unit. * Patient is either on invasive mechanical ventilation, on CPAP or NIPPV or receives respiratory support via high-flow nasal cannula (≥2L/min) * Signed informed consent prior to any study related procedures by the legal representatives of the patient 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 (2)

Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit

Palo Alto, California, United States

Cooper Health System

Camden, New Jersey, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

This 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: 7 days

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

This 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: 7 days

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: 7 days

Central Contacts

Magnus Johnsson, MSc.

CONTACT

+46336163410 magnus.johnsson@neolamedical.com

Data from ClinicalTrials.gov

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