Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 22
- Locations
- 4
- Primary Endpoint
- The number of device related events including skin reactions
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 44 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping(7 days)
- The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates(7 days)
- The adhesive performance of the probes in terms of ability to be repositioned and stay attached(7 days)
- The adhesive performance of the probes in terms of ability to be repositioned and stay attached(7 days)
- The device's ability to continuously measure and present the clinical parameters while the neonates are in a resting state/sleeping(7 days)
- The device's ability to continuously measure and present the clinical parameters during normal handling of the neonates(7 days)