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Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe

NCT03510169 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-10

No results posted yet for this study

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

Interventions

DEVICE

NeoVest

Negative pressure ventilation with NeoVest

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Douglas Campbell, MD · Unity Health Toronto

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Hours
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2024-06-30
Completion
2024-12-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510169 on ClinicalTrials.gov