About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
imminent intubation criteria
refusal by the physician in charge
chronic home ventilation
hemodynamic instability requiring vasopressors
Trial design
Parallel
Treatments tested in this trial
NIV NAVA
DeviceNon-invasive support using NAVA technology
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
% of eligible patients (identified by screening) who are included in the study at each site and overall
Secondary outcomes
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
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
Evolution of the respiratory distress mWCAS score
Evolution of mWCAS
Evolution of the respiratory distress ROX-HR score
Evolution of ROX-HR scores
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: