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
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