NAVA vs. CMV Crossover in Severe BPD

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Mar 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to help infants and young children with severe bronchopulmonary dysplasia (BPD) breathe better while they are on mechanical ventilation. The trial compares a traditional method of mechanical ventilation, called conventional flow-triggered ventilation, with a newer technique known as neurally adjusted ventilatory assist (NAVA). Researchers want to see which method helps with breathing mechanics, gas exchange (how oxygen and carbon dioxide are managed), and overall comfort for the patients. The study includes 20 premature infants and young children who are currently receiving invasive respiratory support and will help us understand which method might be more effective.

To be eligible for this trial, participants must be born prematurely (at or before 32 weeks gestation) and be between 36 weeks and 2 years old corrected age. They should have a diagnosis of severe BPD and need mechanical ventilation for lung support. Parents will need to give their consent for their child to participate. Throughout the study, participants will be monitored closely to assess their breathing and comfort levels with each ventilation method. This research is important as it aims to improve care for young children with serious lung conditions.

Gender

ALL

Eligibility criteria

• 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.