Recruiting

Gentle Synchronized Negative Pressure

Sponsor:

Unity Health Toronto

Code:

NCT03510169

Conditions

Respiratory Distress Syndrome

TTN

RDS of Prematurity

Respiratory Distress, Newborn

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NeoVest

Study Details

Brief summary:

The NeoVest delivery device is a wearable vest/shell that surrounds the infant's abdomen. It was developed using serial body measurements of infants previously admitted to the St. Michael's Hospital NICU (REB #15-183). It gently pulls on the abdomen by applying negative pressure, thereby displacing the diaphragm. The materials used for the NeoVest are lightweight and suitable for the infants' sensitive skin.

The AIM of the present study is to demonstrate the feasibility of applying negative pressure NIV, that is synchronized and proportional to the infant's respiratory demand. The preliminary data on feasibility can be used to apply for larger grants from the CIHR, for a study of the NeoVest in smaller premature infants.

Conditions

Respiratory Distress Syndrome

TTN

RDS of Prematurity

Respiratory Distress, Newborn

Study ID

NCT03510169

Start date

Sep 2, 2019

Status verified date

May, 2023

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 20 infants, admitted to Neonatal Intensive Care Unit (NICU) at St. Michael's Hospital
  • >1.5kg birthweight
  • Clinically stable, with symptoms of respiratory distress (due to transient tachypnea of the newborn, respiratory distress syndrome, etc.)
  • Stable on nasal CPAP (5-8cm H2O) for a minimum of 6 hours
  • Within the first two weeks of life

Exclusion Criteria:

  • Infants with FiO2 requirements >0.35
  • Infants with clinically significant apnoea or bradycardia (> 2 A\&B in last hour, or apnea >20 sec, or bradycardia requiring significant stimulation)
  • Infants with hemodynamic instability (mean BP < weeks GA), or any infant requiring fluid boluses and/or inotropic medications
  • Infants with genetic conditions or dysmorphic facial features
  • Infants that have been recently extubated in the last 48 hours
  • Infants in whom placement of the NG tube is contra-indicated
  • Infants with any clinical suspicion of upper airway distress such as symptoms of stridor
  • Infants with abdominal wall defects and other visible abnormalities of the abdomen or chest
  • Infants with umbilical arterial and/or venous catheters
  • Infants that have allergies and/or previous skin reactions to silicone based materials

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: NeoVest

Negative pressure ventilation using NeoVest

Interventions

NeoVest

Negative pressure ventilation with NeoVest

Primary outcome measure

  • Feasibility of negative pressure ventilation with NeoVest [ Time Frame: 22 minutes ]

Central Contacts and Locations

Central contacts

Douglas Campbell, MD

416-864-6060campbelld@smh.ca

Locations

St. Michael's Hospital NICU

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Douglas Campbell, MD

416-864-5232campbelld@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

May 10, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2023-05-10.