Neola Device for Respiratory Distress Syndrome
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.12345Why 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.36789
Who Is on the Research Team?
Valerie Chock, M.D., M.S. Epi
Principal Investigator
Division of Neonatal and Developmental Medicine Stanford University School of Medicine
Vineet Bhandari, MD, DM
Principal Investigator
Department of Pediatrics The Children's Regional Hospital at Cooper
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Neonates are monitored using the Neola device to assess safety and performance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neola
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neola Medical Inc
Lead Sponsor