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Neola® Lung Monitoring Device for Neonates

This study is testing a new device called Neola® that monitors lung function in babies. It's designed to see if Neola® is safe and works as expected for newborns in the Neonatal Intensive Care Unit (NICU). The study will look at how many device-related issues, like skin reactions, occur and any other serious or non-serious problems within two days. You might be able to join if your baby is between 1 day and 44 weeks old, weighs between 1000g and 3500g, is in the NICU, and needs breathing support. The study plans to enroll 22 babies, but its current status is unclear.

Study design
This is an interventional study involving 22 participants. It aims to assess the safety and performance of the Neola device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two days to monitor device-related events and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07060911

Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Not Yet Recruiting
NAAges 1–44Interventional
Neola Medical Inc
~22 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:Lung monitoring with the Neola device

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of device related events including skin reactions
Measured over 2 days
+1 more outcome measured

Conditions

RDS of Prematurity
Preterm Birth
Lung Diseases

Explore related trials

Lung DisorderPreterm BirthRespiratory Distress Syndrome In Premature Infants

Where it's being run

2 sites across 2 states
California1
New Jersey1

Study leadership

  • 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

Who to contact

Magnus Johnsson, MSc.
[email protected]
+46336163410
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Preterm or term born neonates with gestational age between 26 and 40 weeks
Age between 1 day post-natal and 44 weeks corrected gestational age
Weight between 1000 g and 3500 g
Patient treated at a neonatal intensive care unit.
Patient is either on invasive mechanical ventilation, on CPAP or NIPPV or receives respiratory support via high-flow nasal cannula (≥2L/min)
Signed informed consent prior to any study related procedures by the legal representatives of the patient

Exclusion

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.

What this trial measures

  • The number of device related events including skin reactions2 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 trial2 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.