NCT03510169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.8 years

First QC Date

April 5, 2018

Last Update Submit

May 9, 2023

Conditions

Respiratory Distress SyndromeTTNRDS of PrematurityRespiratory Distress, Newborn

Outcome Measures

Primary Outcomes (1)

  • Feasibility of negative pressure ventilation with NeoVest

    Ability to provide negative pressure ventilation with the NeoVest

    22 minutes

Secondary Outcomes (6)

  • Diaphragm Electrical Activity

    Will be obtained every 1-5 minutes, or following any change in respiratory support

  • Respiratory Rate

    Will be obtained every 1-5 minutes, or following any change in respiratory support

  • Heart Rate

    Will be obtained every 1-5 minutes, or following any change in respiratory support

  • Oxygen Saturation

    Will be obtained every 1-5 minutes, or following any change in respiratory support

  • Transcutaneous Carbon Dioxide Level

    Will be obtained every 1-5 minutes, or following any change in respiratory support

  • +1 more secondary outcomes

Study Arms (1)

NeoVest

EXPERIMENTAL

Negative pressure ventilation using NeoVest

Device: NeoVest

Interventions

NeoVestDEVICE

Negative pressure ventilation with NeoVest

Also known as: Negative Pressure Ventilation
NeoVest

Eligibility Criteria

Age6 Hours - 2 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital NICU

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Distress Syndrome In Premature InfantsPulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Douglas Campbell, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas Campbell, MD

CONTACT

416-864-6060campbelld@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 27, 2018

Study Start

September 2, 2019

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)