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NCT Number: NCT07834723

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

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Key information

Conditions

Severe Bronchiolitis Bronchial Diseases Bronchiolitis Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Pediatric Respiratory Distress Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

NIV NAVA

Device

Non-invasive support using NAVA technology

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. completion of the definitive trial outcomes

    Time frame: from initiation to the end of the 6-month study enrolment period

    completion of the definitive trial outcomes : measurement of intubation rate, duration of ventilatory support, length of PICU and hospital stays

  3. Evolution of the respiratory distress mWCAS score

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

    Evolution of mWCAS

  4. Evolution of the respiratory distress ROX-HR score

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

    Evolution of ROX-HR scores

  5. Evolution of the comfort score

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

    Evolution of the comfort score (FLACC)

  6. Capacity to assess the evolution at 3 months post PICU

    Time frame: 3 months post PICU discharge

    Percentage of patients with assessment of PICS-p at 3 months post discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Emeriaud, MD PhD

CONTACT

[email protected]

5143454708

Lucy Clayton, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Acronym: NAVIGATE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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