NAVA vs Standard Ventilation for Bronchiolitis

Recruiting at 1 trial location

Overseen By Monica Koncicki, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Vasoactive medications

Disqualifiers: Chronic lung disease, Cyanotic heart lesions, Congestive heart failure, Hypotonia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Neurally-Adjusted Ventilatory Assistance (NAVA), a special type of breathing support, can help young children with bronchiolitis breathe more comfortably and avoid more invasive treatments like intubation. NAVA is believed to better match a child's natural breathing patterns compared to standard breathing support. The trial includes two groups: one using NAVA and the other using standard non-invasive mechanical servo ventilation. Children under two years old with bronchiolitis in the pediatric ICU might be suitable candidates, especially if their doctor considers both treatments equally appropriate. As an unphased trial, this study offers a unique opportunity to advance understanding of innovative treatments for bronchiolitis in young children.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Neurally-Adjusted Ventilatory Assistance (NAVA) is safe for pediatric patients with bronchiolitis?

Research has shown that Neurally-Adjusted Ventilatory Assistance (NAVA) is promising and safe for treating children with bronchiolitis. Studies have found that NAVA can ease breathing, indicating comfort and ease of use. In one study, only 9% of infants using NAVA required intubation, which is notably low.

Another study suggested that NAVA might reduce the number of children needing intubation for bronchiolitis, indicating that the treatment is well-tolerated and effective. NAVA's ability to better match a child's natural breathing is believed to improve comfort.

Overall, evidence suggests that NAVA is safe for infants and children and may offer advantages over standard ventilation methods, with few serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NAVA (Neurally-Adjusted Ventilatory Assistance) for bronchiolitis because it offers a more personalized approach to ventilation. Unlike standard non-invasive mechanical ventilation, which uses preset parameters, NAVA adjusts the support based on the patient's own breathing efforts by interpreting signals from the brain to the diaphragm. This could lead to more efficient and comfortable breathing support for patients, potentially reducing the duration of ventilation and improving outcomes.

What evidence suggests that Neurally-Adjusted Ventilatory Assistance is effective for bronchiolitis?

This trial will compare Neurally-Adjusted Ventilatory Assistance (NAVA) with Standard Non-Invasive Mechanical Servo Ventilation for treating bronchiolitis. Research has shown that NAVA helps babies breathe more easily than regular non-invasive breathing support. In studies with infants, NAVA quickly reduced the effort needed to breathe. Additionally, the chance of needing a breathing tube (intubation) dropped to about 9% with NAVA, which is encouraging. Other research suggests that NAVA might lead to better health outcomes, such as improved oxygen levels and lower airway pressure. This indicates that NAVA could ease breathing and help avoid more invasive treatments for children with bronchiolitis. ^{1 2 4 5 6}

Who Is on the Research Team?

Jacqueline Weingarten, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for children under two years old diagnosed with bronchiolitis who are in the pediatric ICU. Specific details about who can't join were not provided.

Inclusion Criteria

My child is under 2 years old and has severe bronchiolitis needing ICU care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive non-invasive ventilation using either standard mode or NAVA mode for bronchiolitis treatment

4 weeks

Continuous monitoring in PICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
• Standard Non-Invasive Mechanical Servo Ventilation

Trial Overview The study compares two types of non-invasive breathing support: standard ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA). It aims to see if NAVA offers better comfort and reduces the need for more intense treatments like intubation.

How Is the Trial Designed?

Group I: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm Experimental Treatment 1 Intervention

This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.

Group II: Standard Non-Invasive Mechanical Servo Ventilation Arm Active Control 1 Intervention

This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

NAVA (Neurally-adjusted ventilator assist) showed a 17% reduction in asynchrony and a 1.74 cmH2O lower peak inspiratory pressure (PIP) compared to conventional ventilation in pediatric patients, indicating improved synchronization and potentially less respiratory effort.

Oxygen saturation was also 1.1% higher with NAVA, suggesting better oxygen delivery, although other measured parameters did not show clinically significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist versus conventional ventilation in the pediatric population: Are there benefits? Karikari, S., Rausa, J., Flores, S., et al.[2020]

In a study involving 170 pediatric intensive care patients, Neurally Adjusted Ventilatory Assist (NAVA) was found to be a safe and effective primary ventilation mode, showing a trend towards shorter ventilator time (3.3 hours for NAVA vs. 6.6 hours for conventional ventilation) and reduced length of stay in the PICU (49.5 hours vs. 72.8 hours).

NAVA also demonstrated a significant reduction in the amount of sedation required for patients, particularly when excluding postoperative cases, indicating that it may enhance patient comfort and reduce medication use during ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. Kallio, M., Peltoniemi, O., Anttila, E., et al.[2018]

In a study involving 53 preterm infants (26 on NAVA and 27 on CIMV), those on Neurally Adjusted Ventilatory Assist (NAVA) required significantly less supplemental oxygen at 28 days of age (46% vs. 78%) and fewer days of invasive ventilator support (7.73 days vs. 17.26 days).

NAVA may facilitate quicker weaning from invasive ventilation and reduce the risk of bronchopulmonary dysplasia in preterm infants with severe respiratory distress syndrome, suggesting it could be a safer and more effective option compared to conventional intermittent mandatory ventilation (CIMV).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist for rapid weaning in preterm infants. Fang, SJ., Su, CH., Liao, DL., et al.[2023]

In a study of 19 preterm infants, neurally adjusted ventilatory assist (NAVA) ventilation did not increase the overall time spent within target oxygen saturation levels, but it resulted in fewer severe desaturation events and required less manual oxygen adjustment compared to conventional ventilation.

NAVA ventilation also led to lower electrical activity of the diaphragm and reduced peak inspiratory pressures, suggesting it may provide a gentler approach to respiratory support for very preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist in ventilated very preterm infants: A crossover study. Oda, A., Parikka, V., Lehtonen, L., et al.[2021]

Neurally-adjusted ventilatory assist (NAVA) significantly improves patient-ventilator interaction compared to pressure support ventilation (PSV), as evidenced by a lower asynchrony index (AI) in 615 adult subjects across 15 studies.

While NAVA shows better interaction metrics, it is associated with longer ICU stays and higher discomfort levels compared to PSV, indicating a need for further research on its overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally-Adjusted Ventilatory Assist Versus Pressure Support Ventilation During Noninvasive Ventilation. Weiyun, T., Linli, S., Liuzhao, C.[2023]

Neurally adjusted ventilatory assist (NAVA) significantly reduces trigger delay and ventilator response times in pediatric patients with bronchiolitis, leading to quicker and more efficient breaths compared to traditional pneumatic triggers.

The use of NAVA also decreases the work of breathing, as indicated by lower pressure-time product measurements, suggesting it may enhance patient comfort and efficiency during ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. Clement, KC., Thurman, TL., Holt, SJ., et al.[2021]

In a study of 11 infants with severe bronchiolitis, the use of neurally adjusted ventilator assist (NAVA) mode significantly reduced patient-ventilator inspiratory asynchronies compared to pressure assist/control (PAC) mode, with an asynchrony index of 3% in NAVA versus 38% in PAC.

NAVA mode also resulted in a shorter trigger delay (44 ms) and fewer ineffective breathing efforts (0.54 events/min) compared to PAC mode (116 ms and 21.8 events/min), indicating improved synchronization and potentially better ventilation for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilator assist (NAVA) reduces asynchrony during non-invasive ventilation for severe bronchiolitis. Baudin, F., Pouyau, R., Cour-Andlauer, F., et al.[2022]

NAVA (Neurally Adjusted Ventilator Assist) is a new ventilatory support method that enhances patient-ventilator synchrony by monitoring the diaphragm's electrical activity, allowing for more responsive breathing assistance.

Preliminary studies indicate that NAVA is safe and well tolerated in both term and preterm infants, but further research is necessary before it can be widely recommended for routine use in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. Biban, P., Serra, A., Polese, G., et al.[2010]

In a study of 63 bronchiolitis patients, non-invasive Neurally Adjusted Ventilatory Assist (NAVA) showed suboptimal compliance with operational parameters, with only 50.4% of patients meeting the ideal diaphragm electrical activity levels.

Patients on NAVA had significantly longer stays in the PICU and took more time to reach minimal respiratory support compared to those on conventional non-NAVA support, suggesting that while NAVA is a newer technology, it may not yet be as effective in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Neurally Adjusted Ventilatory Assist (NAVA) in the pediatric ICU: assessing optimal Edi compliance. Lamsal, R., Fischer, G., Shyne, M., et al.[2021]

In a study of 64 infants with bronchiolitis who failed initial noninvasive support, the use of noninvasive neurally adjusted ventilatory assist (NIV-NAVA) led to a significant reduction in respiratory effort, as indicated by a decrease in the modified Wood Clinical Asthma Score (mWCAS) and electrical diaphragmatic activity (Edi).

The overall intubation rate for patients treated with NIV-NAVA was low at 9%, suggesting that NIV-NAVA can be a safe and effective option for managing respiratory distress in infants with bronchiolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Neurally Adjusted Ventilatory Assist in Infants With Bronchiolitis: Respiratory Outcomes in a Single-Center, Retrospective Cohort, 2016-2018. Lepage-Farrell, A., Tabone, L., Plante, V., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38019615/

Noninvasive Neurally Adjusted Ventilatory Assist in Infants ... The use of NIV-NAVA was associated with a rapid decrease in respiratory effort and a 9% intubation rate.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06053684

NCT06053684 | Non-Invasive Ventilation Versus Neurally- ... Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team ...

3. liebertpub.com liebertpub.com/doi/10.1177/19433654251384560

Interaction of PEEP and Neurally-Adjusted Ventilatory ... We examined the effect of various NAVA, pressure support (PSV), and PEEP combinations in infants with acute viral bronchiolitis.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.27293

Neurally adjusted ventilatory assist (NAVA) in neonatal and ... Most used outcomes were changes in clinical parameters or measurements (such as ventilation peak and mean airway pressures, oxygenation index), ...

5. journals.lww.com journals.lww.com/ccmjournal/fulltext/2024/01001/792__a_descriptive_study_of_niv_nava_utilization.738.aspx

792: a descriptive study of niv-nava utilization in children ... However, data suggests that non-invasive ventilation (NIV) can be effective and safe leading to reduced rates of intubation. In children with bronchiolitis, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1875957222002121

Neurally adjusted ventilatory assist in infants: A review article The aim of this article is to discuss whether NAVA can provide better synchronization and comfort for ventilated newborns and premature babies.