NAVA vs. CMV Crossover in Severe BPD

Mechanical Ventilation Clinical Trial

Official title:

Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821453
• Other study ID #: 19-017175
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: Natalie Napolitano, MPH, RRT-NPS
• Phone: 215-590-1708
• Email: napolitanon[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Mechanical Ventilation
• Neurally Adjusted Ventilatory Assist

Intervention

Device:
• NAVA
NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
• CMV
CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Rhode Island Hospital (Hasboro Children's Hospital)	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	American Respiratory Care Foundation, Children's Miracle Network, Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen saturation (SpO2) index	Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the median, time-weighted daily oxygen saturation (SpO2) index ([mean airway pressure x Fraction of inspired oxygen (FiO2)]/SpO2).	up to 5 days per study arm
Secondary	Sedation Medications	The need for sedation medication will be assessed by comparing the needs for sedation by the total daily dose milligram/kilogram (mg/kg) of sedation medications on invasive mechanical ventilation with NAVA compared to CMV.	up to 5 days per study arm
Secondary	Stress	Patient stress will be assessed by collecting salivary swabs three times per day to measure cortisol levels. The daily average will be assessed and compared as a marker for patient stress on invasive mechanical ventilation with NAVA compared to CMV.	up to 5 days per study arm