NAVA vs. CMV Crossover in Severe BPD

NCT04821453 | Terminated Results DMC FDA Device

• 1 other identifier: 19-017175
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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).

Conditions

Bronchopulmonary Dysplasia; Neurally Adjusted Ventilatory Assist; Mechanical Ventilation

Keywords

BPD; Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (SpO2) Index

  The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. 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 mean, 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 Outcomes (2)

• Sedation Medications

  up to 5 days per study arm

• Stress

  up to 5 days per study arm

Study Arms (2)

Conventional Flow Triggered Mechanical Ventilation (CMV)

PLACEBO COMPARATOR

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

Neurally Adjusted Ventilatory Assist (NAVA)

EXPERIMENTAL

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

Interventions

NAVA 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.

Also known as: Neurally Adjusted Ventilatory Assist

Neurally Adjusted Ventilatory Assist (NAVA)

CMV 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

Also known as: Conventional Flow Triggered Mechanical Ventilation

Conventional Flow Triggered Mechanical Ventilation (CMV)

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational ages (GA) ≤ 32 weeks
• Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
• Severe BPD \[as per National Institutes of Health (NIH) consensus definition\] diagnosed at 36 weeks postmenstrual age
• Receiving invasive mechanical ventilation for ongoing lung disease
• Not expected to be ready for extubation within 11 days following enrollment
• Parental consent

You may not qualify if:

• Severe congenital anomalies
• Known diaphragmatic defect
• Current treatment with high frequency mechanical ventilation
• Do not resuscitate (DNR) Status or Futility of Care
• \>10% leak around the artificial airway,
• Treatment with neuromuscular blockade within 72 hours prior to enrollment
• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Rhode Island Hospital: collaborator
• Children's Miracle Network: collaborator
• American Respiratory Care Foundation: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital (Hasboro Children's Hospital)

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Natalie Napolitano, PhD, RRT-NPS, FAARC
• Organization: The Children's Hospital of Philadelphia

NapolitanoN@chop.edu

215-590-1708

Study Officials

• Erik Jensen, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: September 13, 2021
• Primary Completion: November 8, 2024
• Study Completion: February 28, 2025
• Last Updated: May 20, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)