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

Neola Medical AB

Status

Enrolling

Conditions

RDS of Prematurity

Lung Diseases

Preterm Birth

Treatments

Device: Monitoring

Study type

Interventional

Funder types

Industry

Identifiers

NCT06917326

CIV-24-05-047374 (Other Identifier)

PLN-0654

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

1 to 14 days old

Volunteers

No Healthy Volunteers

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.