Non-invasive ventilation as primary ventilatory support for infants with severe bronchiolitis.
Etienne Javouhey, Audrey Barats, Nathalie Richard...
https://pubmed.ncbi.nlm.nih.gov/18500424/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2025-09-05
130
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to find out if using Neurally-Adjusted Ventilatory Assistance NAVA mode for non-invasive ventilation in children with bronchiolitis improves their comfort and reduces the need for more intense treatments like intubation compared to standard non-invasive ventilation. Bronchiolitis is a common lung infection in young children that can cause breathing difficulties. NAVA has been shown to better match the ventilator support with the childs breathing efforts, which may lead to better breathing support. The study compares two non-invasive ventilation methods the standard mode and the NAVA mode. The NAVA method uses a special catheter placed in the esophagus to monitor the electrical activity of the diaphragm, allowing the ventilator to deliver pressure that matches the childs breathing effort more closely. Children will receive either standard non-invasive ventilation or NAVA ventilation according to the study protocol while in the Pediatric Intensive Care Unit. The researchers will track breathing scores and diaphragm activity to see how these methods affect breathing support and comfort. Participants will be monitored regularly for their respiratory status using a Respiratory Severity Score RSS and measurements of electrical activity in the diaphragm Edi. These assessments are taken about one hour after placing the catheter and then approximately every four hours over a 48-hour period. The study will also observe how long children need non-invasive ventilation, if they require intubation, and any need for increased ventilatory support or sedating medications. The study period lasts up to four weeks or until intubation if needed.
CONDITIONS
Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis
J
Jacqueline Weingarten, MD
M
Monica Koncicki, MD
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Montefiore Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | NAVA Mode Non-Invasive Ventilation | Standard Non-Invasive Ventilation |
|---|---|---|
| What it is | Non-invasive ventilation using the neurally-adjusted ventilatory assistance (NAVA) mode, which delivers support based on the electrical activity of the diaphragm measured via a specialized catheter. | Protocol-guided standard non-invasive mechanical ventilation support, not using NAVA, delivered to infants and children with bronchiolitis in the pediatric ICU. |
| Role in the trial | Experimental study arm: participants randomly assigned to NAVA receive protocol-driven non-invasive ventilation using electrical activity feedback. | Active comparator arm: participants are randomized to standard non-invasive ventilation, representing current conventional ventilatory practice. |
| Primary use | To provide ventilatory support for infants and young children with acute bronchiolitis, aiming to improve patient-ventilator synchrony and reduce work of breathing. | Used to deliver supportive ventilation in pediatric bronchiolitis, stabilizing respiratory function and reducing respiratory distress. |
| How it is given or performed | Delivered through a non-invasive ventilator with the NAVA mode activated, using a specialized catheter inserted to detect diaphragm electrical signals that guide ventilation in real time. | Provided using standard non-invasive mechanical ventilation equipment without electrical diaphragm feedback, following established pediatric ventilation protocols. |
| Evidence status | Published studies and a systematic review report that NAVA improves patient-ventilator synchrony and comfort, and may reduce work of breathing in pediatric non-invasive ventilation. Evidence in bronchiolitis is promising but remains limited to small cohort and physiological studies. | Standard non-invasive mechanical ventilation is supported by established evidence and guidelines as a mainstay for respiratory support in severe pediatric bronchiolitis. |
| Important limitations | Limited published evidence on NAVA in infants with bronchiolitis. Device requires catheter placement and technical expertise; potential challenges exist in patients unable to use nasogastric tubes. | Standard non-invasive mode may be less effective for synchrony and patient comfort, and can trigger patient-ventilator asynchrony in young infants. Needs close monitoring for escalation to invasive ventilation if non-invasive support fails. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks or until intubation
Participants receive either standard non-invasive mechanical ventilation or neurally-adjusted ventilatory assistance (NAVA) non-invasive ventilation to support breathing during bronchiolitis.
Continuous monitoring in the Pediatric Intensive Care Unit during ventilation support
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor