RDS of PrematurityNCT07060911
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
A study testing Lung monitoring with the Neola device in people with RDS of Prematurity and Preterm Birth, run by Neola Medical Inc at 2 sites in United States.
Trial summary
Pivotal 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 44 weeks
- Conditions the study is for
- RDS of Prematurity, Preterm Birth, Lung Diseases
- What is being tested?
- Lung monitoring with the Neola device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cooper Health System
Camden, New Jersey, 08103
Vineet Bhandari, MD, DM, 856-342-2000 ext. 1006156, bhandari-vineet@cooperhealth.edu
Vineet Bhandari, MD, DM
Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit
Palo Alto, California, 94304
Valerie Chock, M.D., M.S. Epi, (650) 497-8800, vchock@stanford.edu
Valerie Chock, M.D., M.S. Epi
About this study
Pivotal 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 during standard NICU procedures on neonates.
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Being tested
- Lung monitoring with the Neola device
- 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.
Lung monitoring with the Neola deviceDevice
Lung monitoring with the Neola device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Lung monitoring with the Neola device Receives: Device: Lung monitoring with the Neola device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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 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: 7 days
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
This 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: 7 days
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: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neola Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valerie Chock, M.D., M.S. Epi, Principal investigator, Division of Neonatal and Developmental Medicine Stanford University School of MedicineVineet Bhandari, MD, DM, Principal investigator, Department of Pediatrics The Children's Regional Hospital at Cooper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060911
- Sponsor's protocol ID
- PLN-0387
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
- ClinicalTrials.gov ID
- NCT07060911
- Acronym / sponsor ID
- PLN-0387
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Keywords
- GASMAS, Spectroscopy, Gas absorption spectroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Neola Medical IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Jul 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.
Pivotal 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 during standard NICU procedures on neonates.
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: Lung monitoring with the Neola deviceLung monitoring with the Neola device |
Who may qualify
- Ages
- 1 day to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| Lung monitoring with the Neola deviceLung monitoring with the Neola device | Device | Arm 1 |
Primary outcome
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.
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.
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: 7 days
The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates
Time frame: 7 days
The adhesive performance of the probes in terms of ability to be repositioned and stay attached
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- 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.
Valerie Chock, M.D., M.S. Epi principal investigator
Division of Neonatal and Developmental Medicine Stanford University School of Medicine
Vineet Bhandari, MD, DM principal investigator
Department of Pediatrics The Children's Regional Hospital at Cooper
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung monitoring with the Neola device in people with RDS of Prematurity and Preterm Birth, run by Neola Medical Inc at 2 sites in United States.
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 0 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: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Johnsson, MSc. (+46336163410, magnus.johnsson@neolamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of device related events including skin reactions (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 11 Jul 2025.