NAVA vs. CMV Crossover in Severe BPD

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia; Mechanical Ventilation; Neurally Adjusted Ventilatory Assist
• Intervention / Treatment: Device: CMV; Device: NAVA

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Napolitano, MPH, RRT-NPS; Phone Number: 215-590-1708; Email: napolitanon@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Natalie Napolitano, MPH, RRT-NPS; Phone Number: 215-590-1708; Email: napolitanon@chop.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital (Hasboro Children's Hospital)
      • Contact: Robin I McKinney, MD; Email: Robin.McKinney@Lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional Flow Triggered Mechanical Ventilation (CMV); Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm	Device: 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; Other Names: Conventional Flow Triggered Mechanical Ventilation
Experimental: Neurally Adjusted Ventilatory Assist (NAVA); Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm	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.; Other Names: Neurally Adjusted Ventilatory Assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Rhode Island Hospital; Children's Miracle Network; American Respiratory Care Foundation
• Investigators: Principal Investigator: Erik Jensen, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: BPD; Bronchopulmonary Dysplasia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 19-017175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes