NAVA vs. CMV Crossover in Severe BPD

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Neurally Adjusted Ventilatory Assist; Bronchopulmonary Dysplasia; Mechanical Ventilation

Treatments: Device: NAVA; Device: CMV

Study type: Interventional

Funder types: Other

Identifiers

NCT04821453

19-017175

Details and patient eligibility

About

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).

Full description

Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. 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 NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.

Enrollment: 25 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gestational ages (GA) ≤ 32 weeks
2. Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
3. Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age
4. Receiving invasive mechanical ventilation for ongoing lung disease
5. Not expected to be ready for extubation within 11 days following enrollment
6. Parental consent

Exclusion criteria

1. Severe congenital anomalies
2. Known diaphragmatic defect
3. Current treatment with high frequency mechanical ventilation
4. Do not resuscitate (DNR) Status or Futility of Care
5. >10% leak around the artificial airway,
6. Treatment with neuromuscular blockade within 72 hours prior to enrollment
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups, including a placebo group

Conventional Flow Triggered Mechanical Ventilation (CMV)

Placebo Comparator group

Description:

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

Treatment:

Device: CMV

Neurally Adjusted Ventilatory Assist (NAVA)

Experimental group

Description:

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

Treatment:

Device: NAVA