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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorSt. Justine's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • NIV NAVA

    Device

    Non-invasive support using NAVA technology

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: NIV-NAVA armActive comparator 1 intervention
Group B: Control arm (usual care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Evolution of the respiratory distress mWCAS score

Evolution of mWCAS

Time frame
at randomization, and after 2, 6, and 24 hours
4

Evolution of the respiratory distress ROX-HR score

Evolution of ROX-HR scores

Time frame
at randomization, and after 2, 6, and 24 hours

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: