Skip to content

Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe

Respiratory Distress Syndrome | RDS of Prematurity | Respiratory Distress, Newborn | TTN

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.

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    6 to 2

Participation Criteria

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 Location

St. Michael's Hospital NICU
St. Michael's Hospital NICU
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Douglas Campbell, MD

[email protected]
416-864-5232
Study Sponsored By
Unity Health Toronto
Participants Required
More Information
Study ID: NCT03510169