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

Starting soon · Not applicable

Conditions studied: RDS of Prematurity, Preterm Birth, Lung Diseases

In brief

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

Key facts

Study ID

NCT07060911

Run by

Neola Medical Inc

People needed

22

Starts

2026-03-01

Expected to finish

2027-02-01

Last updated by the study team

2025-07-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit — Palo Alto, California, United States
• Cooper Health System — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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