Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      Preterm babies have immature lungs and frequent pauses in their breathing which often
      necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of
      the most commonly used tools, but does not always provide enough support. A new option is
      non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with
      gas exchange and may decrease a baby's work of breathing. The investigators plan to study
      very low birth weight preterm babies who are generally well but require some support with
      their breathing. By inserting a special feeding tube with sensors into the stomach, the
      investigators can measure the electrical activity of the diaphragm (EAdi), which is an
      important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV,
      the investigators will be able to measure and compare how each method of support affects a
      baby's breathing. This important study will help us determine the most appropriate breathing
      support for preterm babies.
    

Detailed description: 
      Continuous Positive Airway Pressure is one of the most researched and accepted methods of
      delivering NIV to term and preterm infants. Non-invasive high frequency ventilation is a
      relatively new method of delivering NIV respiratory support in preterm infants. Preliminary
      studies suggest superiority over CPAP, and NIHFV is being increasingly utilized in clinical
      practice in an attempt to prevent intubation and minimize ventilation-induced lung injury in
      preterm infants. However, little is known about its mechanism of action and its effect on
      respiratory mechanics in the newborn. The objective of this study is to compare the effects
      of non-invasive ventilation (NIV) delivered by nasal Continuous Positive Airway Pressure
      (nCPAP) versus Non-Invasive High Frequency Ventilation (NIHFV) on respiratory pattern as
      assessed by the electrical activity of the diaphragm (EAdi) in very low birth weight (VLBW)
      preterm infants.

      We hypothesize that in VLBW preterm infants with relative pulmonary insufficiency, NIHFV will
      reduce respiratory drive and improve ventilation, subsequently resulting in decreased patient
      diaphragm energy expenditure. This would be demonstrated by decreased neural respiratory
      rates and/or decreased peak electrical activity of the diaphragm while breathing on NIHFV
      compared to nCPAP.

      Clinicians are seeking alternative methods for providing non-invasive respiratory support to
      preterm infants. NIHFV is a relatively new modality that is being increasingly utilized in
      clinical practice but has not been well studied. This study will help us determine how
      non-invasive high frequency ventilation (NIHFV) affects breathing in preterm infants, as
      compared to the more traditional modality of nasal CPAP. Therefore, clinicians will not only
      be able to better understand how NIHFV works, but also utilize this information to decide on
      the most appropriate respiratory support modality for preterm patients
    

Intervention name(s): Drager VN500 Ventilator
Intervention type(s): Device
Intervention description(s): This ventilator is capable of providing both nCPAP and NIHFV support.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nCPAP; High-Frequency Oscillator Ventilation; Diaphragm Electrical Activity