NeoVest for Neonatal Respiratory Distress Syndrome

(Neovest Trial)

Overseen by Douglas Campbell, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Unity Health Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the NeoVest, a wearable vest that helps infants with breathing problems by gently pulling on their abdomen. It is designed for premature and full-term infants who need breathing support. The vest assists breathing and synchronizes with the baby's natural breaths.

Research Team

Douglas Campbell, MD

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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.

Inclusion Criteria

I am within the first two weeks of my life.

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.

Exclusion Criteria

My infant has a visible belly or chest abnormality.

My infant has had serious breathing pauses or slow heart rate recently.

My infant has an umbilical catheter.

Treatment Details

Interventions

• NeoVest (Negative Pressure Ventilation)

Trial Overview 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.

Participant Groups

Group I: NeoVest Experimental Treatment 1 Intervention

Negative pressure ventilation using NeoVest

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Dr. Sharon Straus

Unity Health Toronto

Chief Medical Officer

MD and MSc in Clinical Epidemiology, University of Toronto

Altaf Stationwala

Unity Health Toronto

Chief Executive Officer

Bachelor's degree in Health Administration, University of Ottawa