An interventional study of NIV NAVA in Severe Bronchiolitis and Pediatric Respiratory Distress, sponsored by St. Justine's Hospital. Not yet recruiting at 4 sites in Canada. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Treatment
Among 22 studies in Bronchiolitis with a site in Canada — 4 open to participants now, 5 under way, none of them phase 3. Bronchiolitis · Canada.
Among the 22 studies in Bronchiolitis with a site in Canada, this one is the 9th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2026, is one of 9 with no phase, and was the 22nd registered.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
Browse Bronchiolitis studies →4 of the 22 studies in Bronchiolitis with a site in Canada are open now. Recruiting first, the newest first:
Seattle Children's Hospital · Sites in Canada, United States
St. Justine's Hospital · Sites in Canada
St. Justine's Hospital · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 26 Bronchiolitis studies recruiting now, 4 (15%) set no upper age limit and 21 (81%) stop at 75 or younger; 23 take children under 18; 0 take healthy volunteers.
This study: Up to 2 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 4 · Phase 4 1
First in 2001; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 90 is close to the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Median enrollment 105 across the 16 interventional studies, 690 across the 5 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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1 of 22 have an industry lead sponsor. The 10 most frequent:
St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.
St. Justine's Hospital has 4 studies filed under Bronchiolitis — fewer than ten, so there is no comparison to draw.
2 of the studies in Bronchiolitis with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06124092St. Justine's HospitalOutcomes of Children After Hospitalization in Intensive Care Unit | 2027-03 |
| NCT07834723St. Justine's HospitalNIV-NAVA in Infants With Severe Bronchiolitis, a Pilot Multicenter Randomized Controlled Trial | 2027-05 |
Among the 22 studies in Bronchiolitis with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Installation of an Edi catheter. Ventilation with NIV-NAVA as long as a bi-level NIV support is needed.
Device: NIV NAVA
Ventilation according to the clinical team. No NAVA ventilation allowed.
Non-invasive support using NAVA technology
Recruitment rate
% of eligible patients (identified by screening) who are included in the study at each site and overall
Time frame: from initiation to the end of the 6-month study enrolment period
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
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
completion of the definitive trial outcomes : measurement of intubation rate, duration of ventilatory support, length of PICU and hospital stays
Time frame: from initiation to the end of the 6-month study enrolment period
Evolution of the respiratory distress mWCAS score
Evolution of mWCAS
Time frame: at randomization, and after 2, 6, and 24 hours
Evolution of the respiratory distress ROX-HR score
Evolution of ROX-HR scores
Time frame: at randomization, and after 2, 6, and 24 hours
Evolution of the comfort score
Evolution of the comfort score (FLACC)
Time frame: 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
Time frame: 3 months post PICU discharge
Plan to share: 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).
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 7 months is below that.
Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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