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Mechanical Ventilation

NAVA vs. CMV for Severe Bronchopulmonary Dysplasia

N/A

Recruiting

Led By Erik Jensen, MD, MSCE

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving invasive mechanical ventilation for ongoing lung disease

Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age

Must not have

Acute respiratory instability defined as a ventilator rate increase > 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase > 2 cm/water (H2O), sustained FiO2 increase > 20%, and/or prescribed increase in tidal volume > 2 mL/kg within 24 hours prior to enrollment will be excluded.

Current treatment with high frequency mechanical ventilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 days per study arm

Summary

This trial will compare two modes of mechanical ventilation - conventional and neurally adjusted ventilatory assist - for 20 infants with severe bronchopulmonary dysplasia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial description does not specify side effects, both NAVA and CMV can potentially cause discomfort due to the artificial airway used for breathing support. There may also be risks associated with changes in respiratory settings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a ventilator due to lung disease.

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

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I am between 36 weeks postmenstrual age and 2 years old.

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My pregnancy is 32 weeks along or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently on a high-frequency ventilator.

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I have a known issue with my diaphragm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 days per study arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 days per study arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 days per study arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxygen saturation (SpO2) index

Secondary study objectives

Sedation Medications

Stress

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Neurally Adjusted Ventilatory Assist (NAVA)Experimental Treatment1 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 Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NAVA

2013

N/A

~220

0 / 7Eligibility criteria met