Clinical Research Directory

NIV-NAVA in Infants With Severe Bronchiolitis, a Pilot Multicenter Randomized Controlled Trial

Sponsor: St. Justine's Hospital

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. 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.

Official title: Non-invasive Ventilation With NAVA in Infants With Severe Bronchiolitis. A Multicenter Pilot Open Label Pragmatic Randomized Controlled Trial (NAVIGATE Trial)

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