Status:
TERMINATED
NAVA vs. CMV Crossover in Severe BPD
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Rhode Island Hospital
Children's Miracle Network
Conditions:
Bronchopulmonary Dysplasia
Neurally Adjusted Ventilatory Assist
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief Summary
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 ...
Detailed 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 mana...
Eligibility Criteria
Inclusion
- Gestational ages (GA) ≤ 32 weeks
- Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
- Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age
- Receiving invasive mechanical ventilation for ongoing lung disease
- Not expected to be ready for extubation within 11 days following enrollment
- Parental consent
Exclusion
- Severe congenital anomalies
- Known diaphragmatic defect
- Current treatment with high frequency mechanical ventilation
- Do not resuscitate (DNR) Status or Futility of Care
- \>10% leak around the artificial airway,
- Treatment with neuromuscular blockade within 72 hours prior to enrollment
- 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.
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04821453
Start Date
September 13 2021
End Date
February 28 2025
Last Update
August 18 2025
Active Locations (2)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
Rhode Island Hospital (Hasboro Children's Hospital)
Providence, Rhode Island, United States, 02903