Assessing a new lung monitoring device for newborns
Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
This study is testing a new device that continuously checks lung health in newborns to see if it works safely and effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Neola Medical AB Industry-sponsored |
| Locations | 1 site (Borås) |
| Trial ID | NCT06917326 on ClinicalTrials.gov |
What this trial studies
This clinical pilot study evaluates the safety and performance of Neola®, a novel lung monitoring device designed for neonates. The device aims to continuously measure and display lung volume and oxygen gas concentration in preterm and term infants. The study will gather data to inform the design of a larger clinical investigation, ensuring the device functions as intended under real-world conditions.
Who should consider this trial
Good fit: Ideal candidates include preterm or term neonates aged between 1 and 14 days with a gestational age of 28 to 40 weeks and a weight between 1000 g and 3000 g.
Not a fit: Patients with known cardiopulmonary congenital anomalies or severe skin conditions that prevent the use of skin adhesives may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could improve the monitoring of lung health in neonates, leading to better management of respiratory conditions.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Borås
- Södra Älvsborgs Sjukhus — Borås, Sweden (Recruiting)
Study contacts
- Principal investigator: Gustaf Lernfelt — Sodra Alvsborgs Hospital
- Study coordinator: Magnus Johnsson
- Email: magnus.johnsson@neolamedical.com
- Phone: +46708429376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.