Clinical trial NCT04821453: NAVA vs. CMV Crossover in Severe BPD
Official title: Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Neurally Adjusted Ventilatory Assist
Mechanical Ventilation
Keywords: BPD
Bronchopulmonary Dysplasia
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: Children's Miracle Network
name: American Respiratory Care Foundation
First posted: 2021-03-29
Enrollment: 25
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation
Primary purpose: TREATMENT

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 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).

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 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 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.

Primary outcomes:
measure: Oxygen saturation (SpO2) index
timeFrame: up to 5 days per study arm
Secondary outcomes:
measure: Sedation Medications
timeFrame: up to 5 days per study arm
measure: Stress
timeFrame: up to 5 days per study arm
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital (Hasboro Children's Hospital)
state: Rhode Island
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Erik Jensen, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: