Comparing two types of mechanical ventilation for infants with severe bronchopulmonary dysplasia
Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)
This study is testing whether a new type of breathing support called NAVA works better than standard mechanical ventilation for infants and young children with severe bronchopulmonary dysplasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | N/A to 24 Months |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT04821453 on ClinicalTrials.gov |
What this trial studies
This pilot randomized cross-over trial evaluates the effectiveness of neurally adjusted ventilatory assist (NAVA) compared to conventional flow triggered mechanical ventilation in infants and young children with severe bronchopulmonary dysplasia (BPD). The study focuses on measuring pulmonary mechanics, respiratory gas exchange, and patient comfort among 20 participants receiving invasive respiratory support. By investigating these two ventilation modes, the trial aims to identify optimal respiratory management strategies for this vulnerable population. The research is conducted at Children's Hospital of Philadelphia and Rhode Island Hospital.
Who should consider this trial
Good fit: Ideal candidates are infants born at or before 32 weeks gestational age, currently aged between 36 weeks postmenstrual age and 2 years corrected age, diagnosed with severe BPD, and receiving invasive mechanical ventilation.
Not a fit: Patients with severe congenital anomalies, known diaphragmatic defects, or those currently treated with high-frequency mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory support strategies that enhance recovery and neurodevelopment in infants with severe BPD.
How similar studies have performed: While there has been limited research on NAVA in this specific population, similar approaches have shown promise in improving respiratory outcomes in preterm neonates.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Rhode Island Hospital (Hasboro Children's Hospital) — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Erik Jensen, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Natalie Napolitano, PhD, RRT-NPS
- Email: napolitanon@chop.edu
- Phone: 215-590-1708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.