NAVA vs. CMV Crossover in Severe BPD

Description

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

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Study Overview

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Study Details

Study overview

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).

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

NAVA vs. CMV Crossover in Severe BPD

Condition
Bronchopulmonary Dysplasia
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Providence

Rhode Island Hospital (Hasboro Children's Hospital), Providence, Rhode Island, United States, 02903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

to 24 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital of Philadelphia,

Erik Jensen, MD, MSCE, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2025-10