Status:
RECRUITING
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Lead Sponsor:
Neola Medical AB
Conditions:
RDS of Prematurity
Preterm Birth
Eligibility:
All Genders
1-14 years
Phase:
NA
Brief Summary
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
Detailed 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 continu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06917326
Start Date
May 20 2025
End Date
August 31 2025
Last Update
May 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Södra Älvsborgs Sjukhus
Borås, Sweden, Sweden, 501 82