NAVA vs. CMV Crossover in Severe BPD

Last updated: November 11, 2024
Sponsor: Children's Hospital of Philadelphia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Treatment

NAVA

CMV

Clinical Study ID

NCT04821453
19-017175
  • Ages < 24
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 perminute (bpm), Positive end-expiratory pressure (PEEP) increase > 2 cm/water (H2O),sustained FiO2 increase > 20%, and/or prescribed increase in tidal volume > 2 mL/kgwithin 24 hours prior to enrollment will be excluded.

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: NAVA
Phase:
Study Start date:
September 13, 2021
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Rhode Island Hospital (Hasboro Children's Hospital)

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

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