Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
Condition: Preterm Infant; BPD - Bronchopulmonary Dysplasia; Barotrauma
MeSH terms: Bronchopulmonary Dysplasia; Barotrauma
Study type: Interventional

Summary: 
      Extubation failure is a significant problem in preterm neonates and prolonged intubation is a
      well-documented risk factor for development of chronic lung disease. Out of the respiratory
      modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous
      positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are
      the most commonly used.

      A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared
      to nCPAP (30% vs. 40%)

      NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation
      in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment
      of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported
      to improve patient - ventilator synchrony and minimize mean airway pressure and ability to
      wean an infant from a ventilator. However till date there has been no head to head comparison
      of extubation failure in infants managed on NAVA with conventional ventilator strategies.

      In this study the investigators aim to compare primary extubation failure rates in
      infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible
      infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA
      ventilator settings and will be assessed for primary extubation failure (defined as
      reintubation within 5 days after an elective extubation).
    

Detailed description: 
      Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation
      and ventilation. However the coexistence of lung immaturity, weak respiratory drive,
      excessively compliant chest wall, and surfactant deficiency often contribute to dependency on
      mechanical ventilation during the first days or weeks after birth.

      Prolonged mechanical ventilation is associated with high mortality and morbidities including
      ventilator-associated pneumonia, pneumothorax, and bronchopulmonary dysplasia (BPD). Each
      additional week of mechanical ventilation is reported to be associated with an increase in
      the risk of neurodevelopmental impairment. Reduction in the need and duration of invasive
      mechanical ventilation may potentially improve outcome of preterm infants.

      Extubation failure has been independently associated with increased mortality, longer
      hospitalization, and more days on oxygen and ventilatory support. It is critical, therefore,
      to attempt extubation early and at a time when successful extubation is likely.

      A recent Cochrane review compared the use of nasal intermittent positive pressure ventilation
      (NIPPV) with nasal continuous positive airway pressure (nCPAP) in preterm infants after
      extubation and found that NIPPV may be more effective than nCPAP at decreasing extubation
      failure.

      The feasibility of NAVA use has been described in neonatal and pediatric patients. Several
      studies cite a decrease in peak inspiratory pressures, improved synchrony in triggering, and
      more appropriate termination of positive pressure support. Some studies have reported lower
      work of breathing, PaO2/FiO2 ratios (partial pressure of oxygen/ fractional inspired
      oxygen)and MAP. In addition, NAVA has been used for patients who "fight the ventilator," and
      the synchrony improves the ability to wean.

      The use of NIV-NAVA in neonates has promise as a primary mode of ventilation to aid in the
      prevention of intubation and also maintaining successful extubation. Early extubation may be
      enhanced with NIV-NAVA of those neonates requiring intubation for numerous reasons. The
      ability to provide synchronous NIV allows clinicians the opportunity to extubate infants
      earlier with increased confidence than with previous post extubation support.

      However there is lack of scientific evidence on extubation failure rates on NI-NAVA. Trials
      comparing NAVA to conventional ventilators with regard to ventilator associated lung injury,
      ventilator associated pneumonia and decreasing duration of time on the ventilator have not
      yet been reported.
    

Intervention name(s): NAVA; NIPPV
Intervention type(s): Other; Other
Intervention description(s): Infant will be extubated to NAVA, settings based per protocol; Infant will be extubated to NIPPV, settings detailed in protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAVA; Extubation; NIPPV