RDS of PrematurityNCT06917326
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
A study testing Monitoring in people with RDS of Prematurity and Preterm Birth, run by Neola Medical AB at 1 site in Sweden.
Trial summary
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- RDS of Prematurity, Preterm Birth, Lung Diseases
- What is being tested?
- Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 20 May 2025to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
Read the 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 continuously measure and display the relative lung volume and absolute oxygen gas concentration on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Being tested
- Monitoring
- Keywords
- GASMAS, Spectroscopy, Gas absorption spectroscopy
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Premature Birth, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringDevice
Lung monitoring with the Neola device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Device: Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of serious and non-serious adverse events occurring during the trial
The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events.
Outcome measure: The number of serious and non-serious adverse events occurring during the trial.
Measured: 2 days
The number of device related events including skin reactions
The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events. Outcome measure: The number of device related events including skin reactions.
Measured: 2 days
Secondary outcomes (3)
The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping
This exploratory endpoint will be presented as the percentage of the total resting/sleeping time that the device is able to measure the clinical parameters relative lung volume and absolute oxygen concentration.
Measured: 2 hours
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
This exploratory endpoint will be presented as the percentage of the total handling time that the device is able to measure the clinical parameters relative lung volume and absolute oxygen concentration.
Measured: 2 hours
The adhesive performance of the probes in terms of ability to be repositioned and stay attached
The adhesive performance of the probes in terms of ability to be repositioned and stay attached. This exploratory endpoint will be evaluated the percentage of probe adhesives that were able to stay attached for the duration of the measurement session.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 May 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDS of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neola Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gustaf Lernfelt, Principal investigator, Sodra Alvsborgs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917326
- Sponsor's protocol ID
- PLN-0654
- Other IDs
- CIV-24-05-047374
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
- ClinicalTrials.gov ID
- NCT06917326
- Acronym / sponsor ID
- PLN-0654
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Keywords
- GASMAS, Spectroscopy, Gas absorption spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Neola Medical ABIndustry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 continuously measure and display the relative lung volume and absolute oxygen gas concentration on neonates. The results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Monitoring |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitoringLung monitoring with the Neola device | Device | Arm 1 |
Primary outcome
The number of serious and non-serious adverse events occurring during the trial
Time frame: 2 days
The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events. Outcome measure: The number of serious and non-serious adverse events occurring during the trial.
The number of device related events including skin reactions
Time frame: 2 days
The primary objective of the study is to evaluate safety with regards to adverse events (AE) and in particular device related adverse events. Outcome measure: The number of device related events including skin reactions.
3 secondary outcomes
The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping
Time frame: 2 hours
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
Time frame: 2 hours
The adhesive performance of the probes in terms of ability to be repositioned and stay attached
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustaf Lernfelt principal investigator
Sodra Alvsborgs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring in people with RDS of Prematurity and Preterm Birth, run by Neola Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of serious and non-serious adverse events occurring during the trial (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.