Severe BronchiolitisNAVIGATENCT07834723
NIV-NAVA in Infants With Severe Bronchiolitis, a Pilot Multicenter Randomized Controlled Trial
A study testing NIV NAVA in people with Severe Bronchiolitis and Pediatric Respiratory Distress, run by St. Justine's Hospital at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Severe Bronchiolitis, Pediatric Respiratory Distress
- What is being tested?
- NIV NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants younger than 2 years old
- admitted to the PICU (or managed by the PICU team while awaiting PICU admission)
- with a clinical diagnosis of bronchiolitis according to the treating team
- requiring NIV support higher than CPAP/HFNC according to the treating team, a criteria present for less than 8 hours.
Who cannot join
- imminent intubation criteria
- refusal by the physician in charge
- chronic home ventilation
- hemodynamic instability requiring vasopressors
- contraindication to NIV or to gastric tube insertion
- patients in whom a limitation of life-support treatment is considered
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lucy Clayton, MSc contact
Canada4 sites
Alberta Children's Hospital
Calgary, Alberta
Laurie Lee, NPS PhD, 4032206546, laurie.lee@ucalgary.ca
CHU Sainte Justine
Montreal, Quebec
Guillaume Emeriaud, MD PhD, 5143454708, guillaume.emeriaud@umontreal.ca
Montreal Children's Hospital
Montreal, Quebec
Patricia Fontela, MD PhD, 5144124400 ext. 22855, patricia.fontela.med@ssss.gouv.qc.ca
CHEO
Ottawa, Ontario
Dayre McNally, MD, 6137377600, dmcnally@cheo.on.ca
About this study
Official title: Non-invasive Ventilation With NAVA in Infants With Severe Bronchiolitis. A Multicenter Pilot Open Label Pragmatic Randomized Controlled Trial (NAVIGATE 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.
Read more
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.
Read the detailed description
Goal(s) / Research Aims The primary objective of this multicenter pilot RCT is to determine the feasibility of a definitive multicenter RCT that will evaluate whether NIV-NAVA is superior to conventional NIV in infants with severe bronchiolitis who are not adequately supported by HFNC or CPAP. The primary hypothesis is that the pilot RCT will confirm the feasibility of the final trial.
Methods / Approaches This is an investigator-led, multicenter, randomized, controlled, open-label, pragmatic pilot trial conducted in four Canadian pediatric intensive care units (PICUs) with varying levels of experience with NIV-NAVA, supported by the Canadian Critical Care Trials Group (CCCTG).
Ninety infants younger than 2 years old who are admitted to the PICU with a clinical diagnosis of bronchiolitis, who require NIV support greater than CPAP/HFNC, and who have no exclusion criteria will be randomized 1:1 between NIV-NAVA and conventional NIV management.
The pilot trial's feasibility outcomes are the recruitment rate (the primary outcome), adherence to the intervention, and completion of the definitive trial's outcome measures. The primary outcome of the future definitive RCT is the intubation rate. Secondary outcomes will include respiratory distress evolution, comfort, duration of ventilatory support, PICU and hospital length of stay, nutrition and sedation, complication rates, post-PICU functional outcomes, carbon footprint, and cost-effectiveness analysis.
Expertise. An experienced, multidisciplinary team of senior, mid, and early career clinician scientists with unique expertise in pediatric NIV, trial methodology, pediatric respirology, and PICU research is leading this project.
Expected Outcomes. We expect this pilot trial to confirm the feasibility of a definitive trial on NIV-NAVA in severe bronchiolitis. As the first RCT in this understudied field, it will provide much-needed evidence on the most effective strategy for reducing intubation rates in infants with severe bronchiolitis.
- Being tested
- NIV NAVA
- Keywords
- bronchiolitis, pediatric intensive care unit, noninvasive ventilation, NAVA, intubation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV NAVADevice
Non-invasive support using NAVA technology
| Study group | Role | What they receive |
|---|---|---|
| NIV-NAVA arm | Active comparator | Installation of an Edi catheter. Ventilation with NIV-NAVA as long as a bi-level NIV support is needed. Receives: Device: NIV NAVA |
| Control arm (usual care) | No intervention | Ventilation according to the clinical team. No NAVA ventilation allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
% of eligible patients (identified by screening) who are included in the study at each site and overall
Measured: from initiation to the end of the 6-month study enrolment period
Secondary outcomes (6)
adherence to the intervention
In the NAVA arm : % of patients who receive at least 2 hours of NIV-NAVA support, within 2 hours after randomization. In control arm: absence of NAVA use
Measured: during the NIV support period, starting from randomization to the end of the bi-level support NIV (=no NIV-NAVA or BIPAP for at least 48 hours), up to a maximum of 28 days
completion of the definitive trial outcomes
completion of the definitive trial outcomes : measurement of intubation rate, duration of ventilatory support, length of PICU and hospital stays
Measured: from initiation to the end of the 6-month study enrolment period
Evolution of the respiratory distress mWCAS score
Evolution of mWCAS
Measured: at randomization, and after 2, 6, and 24 hours
Evolution of the respiratory distress ROX-HR score
Evolution of ROX-HR scores
Measured: at randomization, and after 2, 6, and 24 hours
Evolution of the comfort score
Evolution of the comfort score (FLACC)
Measured: at randomization, and after 2, 6, and 24 hours
Capacity to assess the evolution at 3 months post PICU
Percentage of patients with assessment of PICS-p at 3 months post discharge
Measured: 3 months post PICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter pilot open label praGmatic rAndomized conTrollEd trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Guillaume Emeriaud, St. Justine's Hospital
- Investigators
- Guillaume Emeriaud, MD PhD, Principal investigator, CHU Sainte Justine, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834723
- Sponsor's protocol ID
- MP-21-2027-10447
- Other IDs
- 583747
- Acronym
- NAVIGATE
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study. If the pilot shows feasibility of a larger trial with no change in the protocol, we may continue the trial with the same protocol and enroll the subjects from the pilot within the larger trial (Vanguard).
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation With NAVA in Infants With Severe Bronchiolitis. A Multicenter Pilot Open Label Pragmatic Randomized Controlled Trial (NAVIGATE Trial)
- ClinicalTrials.gov ID
- NCT07834723
- Acronym / sponsor ID
- NAVIGATE / MP-21-2027-10447
- Keywords
- bronchiolitis, pediatric intensive care unit, noninvasive ventilation, NAVA, intubation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Goal(s) / Research Aims The primary objective of this multicenter pilot RCT is to determine the feasibility of a definitive multicenter RCT that will evaluate whether NIV-NAVA is superior to conventional NIV in infants with severe bronchiolitis who are not adequately supported by HFNC or CPAP. The primary hypothesis is that the pilot RCT will confirm the feasibility of the final trial.
Methods / Approaches This is an investigator-led, multicenter, randomized, controlled, open-label, pragmatic pilot trial conducted in four Canadian pediatric intensive care units (PICUs) with varying levels of experience with NIV-NAVA, supported by the Canadian Critical Care Trials Group (CCCTG).
Ninety infants younger than 2 years old who are admitted to the PICU with a clinical diagnosis of bronchiolitis, who require NIV support greater than CPAP/HFNC, and who have no exclusion criteria will be randomized 1:1 between NIV-NAVA and conventional NIV management.
The pilot trial's feasibility outcomes are the recruitment rate (the primary outcome), adherence to the intervention, and completion of the definitive trial's outcome measures. The primary outcome of the future definitive RCT is the intubation rate. Secondary outcomes will include respiratory distress evolution, comfort, duration of ventilatory support, PICU and hospital length of stay, nutrition and sedation, complication rates, post-PICU functional outcomes, carbon footprint, and cost-effectiveness analysis.
Expertise. An experienced, multidisciplinary team of senior, mid, and early career clinician scientists with unique expertise in pediatric NIV, trial methodology, pediatric respirology, and PICU research is leading this project.
Expected Outcomes. We expect this pilot trial to confirm the feasibility of a definitive trial on NIV-NAVA in severe bronchiolitis. As the first RCT in this understudied field, it will provide much-needed evidence on the most effective strategy for reducing intubation rates in infants with severe bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter pilot open label praGmatic rAndomized conTrollEd trial
| Arm | Type | Receives |
|---|---|---|
| NIV-NAVA arm | Active comparator | Device: NIV NAVAInstallation of an Edi catheter. Ventilation with NIV-NAVA as long as a bi-level NIV support is needed. |
| Control arm (usual care) | No intervention | –Ventilation according to the clinical team. No NAVA ventilation allowed. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants younger than 2 years old
- admitted to the PICU (or managed by the PICU team while awaiting PICU admission)
- with a clinical diagnosis of bronchiolitis according to the treating team
- requiring NIV support higher than CPAP/HFNC according to the treating team, a criteria present for less than 8 hours.
Key exclusion criteria (6 listed)
- imminent intubation criteria
- refusal by the physician in charge
- chronic home ventilation
- hemodynamic instability requiring vasopressors
- contraindication to NIV or to gastric tube insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIV NAVANon-invasive support using NAVA technology | Device | NIV-NAVA arm |
Primary outcome
Recruitment rate
Time frame: from initiation to the end of the 6-month study enrolment period
% of eligible patients (identified by screening) who are included in the study at each site and overall
6 secondary outcomes
adherence to the intervention
Time frame: during the NIV support period, starting from randomization to the end of the bi-level support NIV (=no NIV-NAVA or BIPAP for at least 48 hours), up to a maximum of 28 days
completion of the definitive trial outcomes
Time frame: from initiation to the end of the 6-month study enrolment period
Evolution of the respiratory distress mWCAS score
Time frame: at randomization, and after 2, 6, and 24 hours
Evolution of the respiratory distress ROX-HR score
Time frame: at randomization, and after 2, 6, and 24 hours
Evolution of the comfort score
Time frame: at randomization, and after 2, 6, and 24 hours
Capacity to assess the evolution at 3 months post PICU
Time frame: 3 months post PICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. This is a pilot study. If the pilot shows feasibility of a larger trial with no change in the protocol, we may continue the trial with the same protocol and enroll the subjects from the pilot within the larger trial (Vanguard).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucy Clayton, MSc contact
Guillaume Emeriaud, MD PhD principal investigator
CHU Sainte Justine, Université de Montréal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV NAVA in people with Severe Bronchiolitis and Pediatric Respiratory Distress, run by St. Justine's Hospital at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Emeriaud, MD PhD (5143454708, guillaume.emeriaud@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: from initiation to the end of the 6-month study enrolment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.