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NAVA vs. CMV Crossover in Severe BPD

Recruiting
- 24 years of age
Both
Phase N/A

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Overview

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).

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.

Eligibility

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.

Study details

Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist, Mechanical Ventilation

NCT04821453

Children's Hospital of Philadelphia

25 January 2024

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