NAVA vs. CMV Crossover in Severe BPD

NCT ID: NCT04821453

Last Updated: 2025-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2025-02-28

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.

Conditions

Bronchopulmonary Dysplasia; Neurally Adjusted Ventilatory Assist; Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

CMV

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

NAVA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Neurally Adjusted Ventilatory Assist; Conventional Flow Triggered Mechanical Ventilation

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.

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Children's Miracle Network

OTHER

Sponsor Role: collaborator

American Respiratory Care Foundation

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Jensen, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Rhode Island Hospital (Hasboro Children's Hospital)

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

19-017175

Identifier Type: -

Identifier Source: org_study_id