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

NCT07060911 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PLN-0387
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

RDS of Prematurity; Preterm Birth; Lung Diseases

Keywords

GASMAS; Spectroscopy; Gas absorption spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

Other Outcomes (1)

• Evaluate the correlation between Neola® measured clinical data and clinical data available from other monitoring devices, procedures or tests.

  7 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Lung monitoring with the Neola device

Device: Lung monitoring with the Neola device

Interventions

Lung monitoring with the Neola device DEVICE

Lung monitoring with the Neola device

Arm 1

Eligibility Criteria

• Age: 1 Day - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neola Medical Inc: lead

Study Sites (2)

Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit

Palo Alto, California, 94304, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Premature Birth; Lung Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Diseases

Study Officials

• Valerie Chock, M.D., M.S. Epi

  Division of Neonatal and Developmental Medicine Stanford University School of Medicine

  PRINCIPAL INVESTIGATOR

• Vineet Bhandari, MD, DM

  Department of Pediatrics The Children's Regional Hospital at Cooper

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Johnsson, MSc.

CONTACT

+46336163410; magnus.johnsson@neolamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)