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

Launched by NEOLA MEDICAL INC · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called Neola®, designed to help monitor the lungs of newborn babies, especially those born early or with lung problems. The main goal is to see if this device is safe to use and works well in babies who need special breathing support in the neonatal intensive care unit (NICU).

Babies who might join the study are those born between 26 and 40 weeks of pregnancy, weighing between 1,000 and 3,500 grams (about 2 to 7.5 pounds), and who are between 1 day old and about 10 weeks corrected age (which accounts for early birth). These babies also need to be receiving breathing support through machines like ventilators, CPAP, or high-flow oxygen. Families will be asked for permission before any study procedures begin. Babies with certain heart or lung birth defects, genetic conditions, severe skin problems, or those who are very ill and not expected to survive will not be included. If a baby joins the study, the device will be used to monitor their lungs carefully to help doctors better understand how it works and how safe it is.

Gender

ALL

Eligibility 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.