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

Neola Medical Inc

Status

Begins enrollment this month

Conditions

RDS of Prematurity

Lung Diseases

Preterm Birth

Treatments

Device: Lung monitoring with the Neola device

Study type

Interventional

Funder types

Industry

Identifiers

NCT07060911

PLN-0387

Details and patient eligibility

About

Pivotal 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 during standard NICU procedures on neonates.

Enrollment

22 estimated patients

Sex

All

Ages

1 day to 44 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.