Your session is about to expire
← Back to Search
Negative Pressure Ventilation
NeoVest for Neonatal Respiratory Distress Syndrome (Neovest Trial)
N/A
Recruiting
Led By Douglas Campbell, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Within the first two weeks of life
Clinically stable, with symptoms of respiratory distress (due to transient tachypnea of the newborn, respiratory distress syndrome, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 minutes
Awards & highlights
Neovest Trial Summary
This trial tested a device that gently pulls on the abdomen of preemies to help them breathe better. It was successful and can be used to apply for larger grants.
Who is the study for?
This trial is for babies over 1.5kg who are stable but have breathing difficulties like transient tachypnea or respiratory distress syndrome, and have been on nasal CPAP for at least 6 hours within their first two weeks of life. Babies with high oxygen needs, upper airway distress, significant apnoea/bradycardia, unstable blood pressure, recent extubation, certain catheters in place or allergies to silicone can't participate.Check my eligibility
What is being tested?
The study tests the NeoVest device—a wearable vest that applies gentle negative pressure on a baby's abdomen to help with breathing. It aims to show this method is feasible and synchronized with the infant's own breaths. The data will support applications for larger studies.See study design
What are the potential side effects?
Potential side effects may include skin irritation due to the vest material or discomfort from the negative pressure application. However, specific side effects will be monitored as part of the study's aim to establish feasibility.
Neovest Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am within the first two weeks of my life.
Select...
My newborn is stable but has breathing difficulties.
Select...
I have been using a CPAP machine at a low pressure setting for at least 6 hours.
Neovest Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of negative pressure ventilation with NeoVest
Secondary outcome measures
Blood Pressure
Diaphragm Electrical Activity
Heart Rate
+3 moreNeovest Trial Design
1Treatment groups
Experimental Treatment
Group I: NeoVestExperimental Treatment1 Intervention
Negative pressure ventilation using NeoVest
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
541 Previous Clinical Trials
447,820 Total Patients Enrolled
Douglas Campbell, MDPrincipal InvestigatorUnity Health Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has a visible belly or chest abnormality.My infant has had serious breathing pauses or slow heart rate recently.I am within the first two weeks of my life.My infant has an umbilical catheter.Babies who have had allergic reactions or skin problems from silicone-based materials.My infant needs extra oxygen (more than 35% oxygen in the air they breathe).My infant was recently taken off a ventilator.My infant has a genetic condition or unusual facial features.My infant shows signs of breathing difficulty.This criterion refers to 20 babies who are currently in the Neonatal Intensive Care Unit at St. Michael's Hospital.You weighed more than 1.5 kilograms at birth.My infant has unstable blood pressure or needs special medication for heart and blood flow.My newborn is stable but has breathing difficulties.I have been using a CPAP machine at a low pressure setting for at least 6 hours.My infant cannot have an NG tube placed.
Research Study Groups:
This trial has the following groups:- Group 1: NeoVest
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research project accept those aged seventy and up as participants?
"This medical trial is recruiting patients between 6 Hours and 2 Weeks of age."
Answered by AI
What is the number of participants receiving treatment in this trial?
"Affirmative. Information hosted on clinicaltrials.gov suggests that this trial is still open to patient enrollment, originally posted in September 2nd 2019 and updated May 9th 2023. Twenty participants are required for recruitment from a single site."
Answered by AI
What criteria must be met for someone to participate in this clinical research?
"Individuals with transient tachypnea of the newborn, aged between 6 hours and 2 weeks old, are eligible to join this research study. A total of 20 candidates will be accepted."
Answered by AI
Is there currently an open call for participants in this trial?
"Clinicaltrials.gov data verifies that this medical trial is seeking patients for participation. It was first published on September 2nd 2019 and its information was last revised on May 9th 2023."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger