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Starting soon Not applicable

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

NCT07060911 · tracked via the Priya Life Science USA tracker
Sponsor
Neola Medical Inc
Phase
Not applicable
Started
2026-03
Last updated
2025-07-11

Condition(s) studied

RDS of PrematurityPreterm BirthLung Diseases

Investigational drug(s) / intervention(s)

Lung monitoring with the Neola device

Lung monitoring with the Neola device: Lung monitoring with the Neola device

Study summary

Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates

Eligibility

Sex
ALL
Min age
1 Day
Max age
44 Weeks
Healthy volunteers
No
IInclusion criteria: * 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 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.

Primary outcome measure(s)

  • The number of device related events including skin reactions — 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 — 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.

Trial sites (2)

FacilityCityRegionStatus
Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit Palo Alto California
Cooper Health System Camden New Jersey
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060911 on ClinicalTrials.gov ↗ ← All trials in the USA