NAVA vs. CMV for Severe Bronchopulmonary Dysplasia

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of breathing support for infants and young children with severe bronchopulmonary dysplasia (BPD), a serious lung condition. It compares conventional mechanical ventilation (CMV) with a newer method called neurally adjusted ventilatory assist (NAVA), which adapts to the child’s breathing signals. The researchers aim to determine which method better supports breathing, gas exchange, and comfort. Infants or young children born prematurely and currently on a ventilator due to severe BPD might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance care for children with severe BPD.

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 prior data suggests that these ventilation methods are safe for infants with severe bronchopulmonary dysplasia?

Research shows that neurally adjusted ventilatory assist (NAVA) might be a safe treatment for infants and young children with severe bronchopulmonary dysplasia (BPD). Some studies suggest that using NAVA early in life could lower the risk of death. However, more research is needed to determine if NAVA is safe and effective for children with severe BPD, as some studies lack clear results.

NAVA adjusts the ventilator based on the baby's own breathing signals, helping the machine better match the baby's natural breathing. This method has been linked to better coordination between the baby and the ventilator and more days without needing the ventilator, suggesting it might be well-tolerated.

While NAVA seems promising, more research is necessary to fully understand its safety for this group of patients. Participants should consult their healthcare providers about any questions or concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neurally Adjusted Ventilatory Assist (NAVA) because it offers a unique approach to treating severe bronchopulmonary dysplasia. Unlike conventional mechanical ventilation (CMV), which relies on preset airflow triggered by the patient's breathing, NAVA uses the patient’s own neural respiratory signals to adjust ventilation in real-time. This personalized method could lead to more efficient lung support with potentially fewer complications. By aligning ventilation support more closely with the patient’s natural breathing efforts, NAVA may improve respiratory outcomes and patient comfort.

What evidence suggests that these ventilation methods could be effective for severe bronchopulmonary dysplasia?

This trial will compare Neurally Adjusted Ventilatory Assist (NAVA) with Conventional Mechanical Ventilation (CMV) for infants with severe bronchopulmonary dysplasia (BPD). Research has shown that NAVA can help infants with severe lung problems breathe better. Studies suggest that NAVA might reduce the need for other medicines, such as corticosteroids, in very premature babies, potentially easing their breathing. However, more research is needed to fully understand NAVA's effectiveness for severe BPD. ^{2 3 4 6 7}

Who Is on the Research Team?

Erik A Jensen, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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