Neola Device for Respiratory Distress Syndrome

Not yet recruiting at 1 trial location

Overseen By Magnus Johnsson, MSc.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Neola Medical Inc

Disqualifiers: Cardiopulmonary anomalies, Chromosomal abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Neola, designed to monitor the lungs of newborns with breathing problems. The goal is to determine if Neola is safe and effective for babies born prematurely or experiencing breathing difficulties. The trial seeks newborns in a neonatal intensive care unit who receive breathing support, such as a ventilator or high-flow nasal cannula. By providing better monitoring, the trial aims to improve care for babies with respiratory distress syndrome. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance neonatal care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Neola device is safe for neonates?

Research has shown that the Neola® device provides a safe and gentle way to monitor newborns' lungs. It tracks the baby's air intake and oxygen levels, ensuring proper breathing. The device operates without causing harm or discomfort to the baby.

The Neola® device is still undergoing tests to confirm its safety and effectiveness. As a non-invasive device, it does not involve surgery or entering the body, making it generally comfortable for newborns. To date, no negative effects have been reported from using the Neola® device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Respiratory Distress Syndrome (RDS), which often involve mechanical ventilation and surfactant therapy, the Neola device offers a novel approach by providing continuous lung monitoring. Researchers are excited about this technology because it uses a non-invasive method to track lung function in real-time, potentially allowing for more precise and timely interventions. This could lead to better outcomes by reducing the risks associated with traditional invasive procedures and improving the management of RDS.

What evidence suggests that the Neola device is effective for respiratory distress syndrome?

Studies have shown that the Neola device, a new tool for monitoring newborns' lungs, may help manage Respiratory Distress Syndrome (RDS). This trial will evaluate the Neola device, which uses gentle breathing support methods associated with shorter hospital stays and lower costs. This approach may lead to fewer complications and better health outcomes for babies. While specific results for Neola are still being gathered, it is expected to enhance how doctors monitor and treat RDS in newborns. The aim is to provide safer and more effective care for these vulnerable patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Vineet Bhandari, MD, DM

Principal Investigator

Department of Pediatrics The Children's Regional Hospital at Cooper

Valerie Chock, M.D., M.S. Epi

Principal Investigator

Division of Neonatal and Developmental Medicine Stanford University School of Medicine

Are You a Good Fit for This Trial?

This trial is for newborn babies who were born prematurely and are experiencing lung-related health issues such as Respiratory Distress Syndrome or other pulmonary diseases. Specific eligibility details are not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

My weight is between 1 kg and 3.5 kg.

My baby was treated in the neonatal intensive care unit.

My baby was born between 26 and 40 weeks of pregnancy.

Exclusion Criteria

Patients not expected to survive

Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin

I have a chromosomal abnormality like trisomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Neonates are monitored using the Neola device to assess safety and performance

7 days

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days

What Are the Treatments Tested in This Trial?

Interventions

• Neola

Trial Overview

The focus of this trial is on a new device called Neola®, which monitors the lungs of premature infants. The study aims to evaluate how safe and effective this device is in a clinical setting.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Lung monitoring with the Neola device

Who Is Running the Clinical Trial?

Neola Medical Inc

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11048199/

The Outcomes of Preterm Infants with Neonatal Respiratory ...

The average RDS severity for the NCPAP group was 3.13, while the NIPPV group had an average severity of 2.71. After MIST, a total of 32 newborns ...

2.

withpower.com

withpower.com/trial/phase-premature-birth-2-2026-f38c7

Neola Device for Respiratory Distress Syndrome

The study aims to evaluate how safe and effective this device is in a clinical setting. How Is the Trial Designed? 1Treatment groups. Experimental Treatment.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8362839/

Resource utilization patterns using non-invasive ventilation ...

There was a three-fold increase in NIV use within the 15-year study period. NIV use was associated with decreased LOS, charges and costs ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1355184125000031

Neonatal respiratory outcomes following nebulised ...

No statistically significant differences were found for duration of mechanical ventilation or development of bronchopulmonary dysplasia.

5.

bmcpulmmed.biomedcentral.com

bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02819-4

Construction and evaluation of neonatal respiratory failure risk ...

The aim of this study was to establish and validate a nomogram model for predicting the probability of respiratory failure in NRDS patients.

6.

neolamedical.com

neolamedical.com/lung-monitoring/

Lung Monitoring - Neola Medical EN

Neola Medical's Neola® can offer a safe and non-invasive way to continuously measure lung volume changes and oxygen gas saturation in the lungs of preterm born ...

7.

trialx.com

trialx.com/clinical-trials/listings/323483/study-to-assess-safety-and-performance-of-neola-a-novel-lung-monitoring-device-for-neonates/

Study to Assess Safety and Performance of Neola®, a ...

The purpose of the study is to demonstrate that the device is safe and performs as intended under anticipated use conditions. The performance of ...

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK560779/

Neonatal Respiratory Distress Syndrome - StatPearls - NCBI

Neonatal respiratory distress syndrome, or RDS, is a common cause of respiratory distress in a newborn, presenting within hours after birth.

9.

htsyndication.com

htsyndication.com/us-fed-news/article/clinical-trial%3A-pivotal-study-to-assess-safety-and-performance-of-neola-r-%2C-a-novel-lung-monitoring-device-for-neonates/555741871

Pivotal Study to Assess Safety and Performance of Neola ...

Brief Summary: Pivotal study to assess safety and performance of Neola(R), a novel lung monitoring device for neonates. Study Start Date ...