Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung monitoring with the Neola device.
- Who it may be relevant to
- Registry conditions: RDS of Prematurity, Preterm Birth, Lung Diseases. Basic parameters: 1 Day — 44 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Lung monitoring with the Neola device
Lung monitoring with the Neola device
Primary outcome measures
- The number of device related events including skin reactions [Time frame: 2 days]
- The number of serious and non-serious adverse events occurring during the trial [Time frame: 2 days]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit — Palo Alto
- Cooper Health System — Camden
Identifiers
NCT: NCT07060911 · PLN-0387