NAVA vs. CMV for Severe Bronchopulmonary Dysplasia

Recruiting at 1 trial location

Overseen By Natalie Napolitano, PhD, RRT-NPS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Neuromuscular blockers

Disqualifiers: Congenital anomalies, Diaphragmatic defect, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, if you are on neuromuscular blockers, you must not have taken them within 72 hours before joining the trial.

What data supports the effectiveness of the treatment NAVA for severe bronchopulmonary dysplasia?

Research shows that NAVA (Neurally Adjusted Ventilatory Assist) can improve breathing support in infants with severe lung conditions by better matching the ventilator's help to the baby's own breathing efforts. Studies found that NAVA led to better oxygen levels and less pressure on the lungs compared to other ventilation methods. ^{1 2 3 4 5}

How does the NAVA treatment differ from other treatments for severe bronchopulmonary dysplasia?

NAVA (Neurally Adjusted Ventilatory Assist) is unique because it uses a special tube with electrodes to monitor the diaphragm's electrical activity, allowing the ventilator to adjust support based on the baby's breathing effort. This can improve synchronization between the patient and the ventilator, potentially reducing the duration of ventilation and related complications compared to conventional methods. ^{4 6 7 8 9}

What is the purpose of this trial?

This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).

Research Team

Erik A Jensen, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for prematurely born infants and young children up to 2 years old with severe bronchopulmonary dysplasia (BPD). They must be on invasive mechanical ventilation, not expected to be extubated within 11 days of joining, and have parental consent. Infants with certain health conditions or recent treatments are excluded.

Inclusion Criteria

I am on a ventilator due to lung disease.

You are not expected to be able to breathe without a ventilator within 11 days after joining the study.

My baby was diagnosed with severe BPD at 36 weeks postmenstrual age.

Exclusion Criteria

You have more than 10% air leaking around the breathing tube.

I haven't needed significant changes to my breathing support settings in the last 24 hours.

You have a "do not resuscitate" (DNR) status or if further treatment is unlikely to help.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will undergo a cross-over trial comparing NAVA and CMV modes of mechanical ventilation, with data collected over a 5-day period for each mode.

10 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• CMV
• NAVA

Trial Overview The study compares two types of breathing support in severely ill babies: conventional mechanical ventilation (CMV) and neurally adjusted ventilatory assist (NAVA). It will look at lung function, oxygen exchange, and comfort levels during treatment in a small group of patients.

Participant Groups

Group I: Neurally Adjusted Ventilatory Assist (NAVA) Experimental Treatment 1 Intervention

Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm

Group II: Conventional Flow Triggered Mechanical Ventilation (CMV) Placebo Group 1 Intervention

Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm

CMV is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Conventional Mechanical Ventilation for:

• Respiratory failure
• Acute respiratory distress syndrome
• Chronic obstructive pulmonary disease
• Bronchopulmonary dysplasia

Approved in United States as Conventional Mechanical Ventilation for:

• Respiratory failure
• Acute respiratory distress syndrome
• Chronic obstructive pulmonary disease
• Bronchopulmonary dysplasia

Approved in Canada as Conventional Mechanical Ventilation for:

• Respiratory failure
• Acute respiratory distress syndrome
• Chronic obstructive pulmonary disease
• Bronchopulmonary dysplasia

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

American Respiratory Care Foundation

Collaborator

Trials

1

Recruited

30+

Children's Miracle Network

Collaborator

Trials

23

Recruited

1,800+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Findings from Research

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]

In a study of 29 preterm infants with bronchopulmonary dysplasia, transitioning from synchronized intermittent mandatory ventilation to neurally adjusted ventilatory assist significantly improved ventilator variables, including decreased peak inspiratory pressure and work of breathing, along with better blood gas values.

The use of neurally adjusted ventilatory assist also led to lower oxygen requirements and improved oxygen saturation, suggesting it may be an effective weaning strategy for infants requiring prolonged mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally Adjusted Ventilatory Assist in Preterm Infants With Established or Evolving Bronchopulmonary Dysplasia on High-Intensity Mechanical Ventilatory Support: A Single-Center Experience. Jung, YH., Kim, HS., Lee, J., et al.[2018]

In a study of 9 very prematurely born infants with bronchopulmonary dysplasia, neurally adjusted ventilator assist (NAVA) significantly improved oxygenation, showing a lower oxygenation index (OI) of 7.9 compared to 11.1 on assist control ventilation (ACV).

NAVA also resulted in lower inspired oxygen concentrations, peak inflation pressures, and mean airway pressures, while increasing lung compliance, indicating it may be a safer and more effective ventilation strategy for these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crossover study of assist control ventilation and neurally adjusted ventilatory assist. Shetty, S., Hunt, K., Peacock, J., et al.[2022]

Neurally Adjusted Ventilatory Assist (NAVA) may enhance the synchronization between preterm newborns and ventilators, potentially reducing the duration of mechanical ventilation and its associated complications.

In a case study of two preterm infants with severe respiratory distress syndrome, NAVA successfully facilitated weaning and extubation, suggesting it could be a beneficial approach, though further research is needed to evaluate long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Successful weaning and extubation in the premature newborn using neurally adjusted ventilatory assist]. García-Muñoz Rodrigo, F., Rivero Rodríguez, S., Florido Rodríguez, A., et al.[2016]

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 involving 18 preterm infants with bronchopulmonary dysplasia, both Proportional Assist Ventilation (PAV) and Neurally Adjusted Ventilatory Assist (NAVA) significantly improved oxygenation compared to conventional ventilation, as measured by the oxygenation index (OI).

While there was no significant difference in the mean OI between PAV and NAVA, the alveolar-arterial (A-a) oxygen gradient was better with NAVA, indicating it may provide more effective oxygenation support in these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Hunt, KA., Dassios, T., Greenough, A.[2021]

Infants with evolving or established bronchopulmonary dysplasia (BPD) who received neurally adjusted ventilatory assist (NAVA) or noninvasive NAVA had significantly lower extubation failure rates and shorter durations of invasive ventilation compared to historical controls.

The overall length of hospital stay was also reduced for infants on NAVA/NIV-NAVA, indicating potential benefits of this ventilation strategy in managing preterm infants with BPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurally Adjusted Ventilatory Assist in Very Prematurely Born Infants with Evolving/Established Bronchopulmonary Dysplasia. Shetty, S., Evans, K., Cornuaud, P., et al.[2021]

In a study involving 21 infants post-open-heart surgery, Neurally Adjusted Ventilatory Assist (NAVA) demonstrated similar hemodynamic effects to Pressure Support Ventilation (PSV), indicating it is a safe alternative for this patient population.

NAVA required significantly lower peak inspiratory pressure (PIP) to maintain carbon dioxide levels compared to PSV, suggesting it may provide more comfortable ventilation while still effectively managing gas exchange.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of neurally adjusted ventilatory assist in infants who underwent cardiac surgery for congenital heart disease]. Zhu, LM., Shi, ZY., Ji, G., et al.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Neurally Adjusted Ventilatory Assist in Infants With Bronchiolitis: Respiratory Outcomes in a Single-Center, Retrospective Cohort, 2016-2018. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Neurally Adjusted Ventilatory Assist in Preterm Infants With Established or Evolving Bronchopulmonary Dysplasia on High-Intensity Mechanical Ventilatory Support: A Single-Center Experience. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Crossover study of assist control ventilation and neurally adjusted ventilatory assist. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

[Successful weaning and extubation in the premature newborn using neurally adjusted ventilatory assist]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist (NAVA) in pediatric intensive care--a randomized controlled trial. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Neurally adjusted ventilatory assist for rapid weaning in preterm infants. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Neurally Adjusted Ventilatory Assist in Very Prematurely Born Infants with Evolving/Established Bronchopulmonary Dysplasia. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[Application of neurally adjusted ventilatory assist in infants who underwent cardiac surgery for congenital heart disease]. [2009]