Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe (NCT03510169) | Clinical Trial Compass
UnknownNot Applicable
Use of Gentle Synchronized Negative Pressure in Helping Babies Breathe
Canada20 participantsStarted 2019-09-02
Plain-language 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.
Who can participate
Age range
6 Hours – 2 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of negative pressure ventilation with NeoVest