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

Launched by NEOLA MEDICAL AB · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new device called Neola®, which is designed to monitor lung health in newborns, especially those who are premature or have lung issues. The main goal is to see how safe the device is and how well it works. The trial is not yet recruiting participants, but it aims to include newborns aged 1 to 14 days who were born between 28 and 40 weeks of pregnancy and weigh between 1,000 to 3,000 grams. To participate, parents or legal guardians will need to provide consent and understand what the study involves.

Participants can expect to have the Neola® device used to monitor their lung function, which could help doctors better understand and manage their respiratory health. However, some babies may not qualify for the study, particularly those with certain heart or lung conditions, skin issues that prevent the use of adhesive devices, or severe health concerns that make survival unlikely. This trial will provide valuable information that could improve care for newborns with lung problems in the future.

Gender

ALL

Eligibility criteria

• 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.