NIV-NAVA for Bronchiolitis

(NAVIGATE Trial)

Not yet recruiting at 3 trial locations
GE
LC
Overseen ByLucy Clayton, MSc
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: St. Justine's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Severe bronchiolitis is a common lung infection in babies that can cause serious breathing problems and often leads to hospitalization in pediatric intensive care units (PICUs). Many infants need special breathing support, usually through non-invasive methods like high-flow oxygen or continuous airway pressure. However, these methods don't always work, and about one in four infants end up needing a breathing tube (intubation), which comes with more risks and a longer recovery.

A newer breathing support method called NIV-NAVA (non-invasive ventilation with neurally adjusted ventilatory assist) may help. It uses signals from the baby's diaphragm to adjust the support in real-time, making breathing easier and possibly reducing the need for intubation. While early results are promising, no high-quality clinical trial has yet tested if NIV-NAVA is better than standard non-invasive support.

This study is a pilot trial - a small-scale version of a larger future study - happening in four PICUs across Canada. It will include 90 babies under 2 years old with severe bronchiolitis who need more support than standard methods provide. Half will receive NIV-NAVA, and half will receive the usual care.

The main goal of this pilot is to check if a larger trial is doable: Can we recruit enough babies? Can the PICU teams stick to the treatment plan? Can we collect the right information? The full study will eventually look at whether NIV-NAVA really lowers the number of babies who need intubation and improves recovery.

This research is led by a team of pediatric experts and could pave the way for better care for thousands of infants with severe breathing problems.

Who Is on the Research Team?

GE

Guillaume Emeriaud, MD PhD

Principal Investigator

CHU Sainte Justine, Université de Montréal

Are You a Good Fit for This Trial?

This trial is for babies under 2 years old with severe bronchiolitis who are in the ICU and need more breathing support than standard non-invasive methods can provide.

Inclusion Criteria

I am younger than 2 years old.
I have needed advanced breathing support (more than CPAP/HFNC) for less than 8 hours.
I am currently in the PICU or under PICU team care while waiting for admission.
See 1 more

Exclusion Criteria

Chronic home ventilation
Patients in whom a limitation of life-support treatment is considered
I am at immediate risk of needing a breathing tube.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • NIV-NAVA

Trial Overview

The study compares a new breathing support method called NIV-NAVA, which adjusts to the baby's own breathing signals, against usual non-invasive care. Babies are randomly assigned to one of these two groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: NIV-NAVA armActive Control1 Intervention
Group II: Control arm (usual care)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials
205
Recruited
87,300+