Comparison Between Infant Flow SiPAP and Noninvasive NAVA in the Neonatal Intensive Care Unit
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      When babies are born premature, they often need help with their breathing. The equipment used
      to help them breathe is not very comfortable and they sometimes need to be put on a
      specialized breathing machine with a tube into their lungs. The breathing machine or
      ventilator can be damaging to the newborn's lungs and more damage can occur the longer the
      newborn stays on a ventilator leading to chronic lung disease later in their lives. A new
      device called neurally adjusted ventilatory assist or NAVA is available that the
      investigators believe may be more comfortable for the premature newborn and may help the baby
      come off breathing support sooner. When using this device, babies may not need to be put on a
      ventilator and can avoid the lung damage associated with the breathing tube and the
      ventilator. The objective of this pilot study is to compare this new breathing device called
      NAVA, to the equipment that is currently being used, called SiPAP, to support premature
      newborn's breathing after birth without a breathing tube. The investigators hope to show that
      with this new technology, premature newborns that are having a difficult time breathing, will
      come off breathing support sooner compared to the breathing machines that are currently being
      used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA
      will decrease time spent on noninvasive ventilation and avoid intubation.
    


Intervention name(s): Neurally Adjusted Ventilatory Assist (NAVA); SiPAP - placebo
Intervention type(s): Device; Device
Intervention description(s): Neurally adjusted ventilatory assist (NAVA), an adjunct that can only be used with the Servo-i ventilator, allows the patient to synchronize spontaneous respiratory effort with mechanical ventilation. NAVA uses the electromyographic signal of the diaphragm (Edi) to transmit this electrical activity back to the ventilator. The NAVA catheter is a functional gastric tube that has electrodes embedded within it and positioned at the level of diaphragm using an electrocardiogram signal. These electrodes continuously (every 5ms) detect the amplitude, duration, and frequency of the Edi and provide pressure support in proportion to this electrical activity. Proportionality is controlled by a NAVA factor (cmH20/microvolt) and is adjusted by the user.; The Infant Flow® SiPAP provides noninvasive support to neonates. CPAP and Biphasic modes are provided by the Infant Flow® SiPAP. CPAP is an elevated pressure (above atmospheric) and is used to increase a premature babies functional residual capacity (FRC). CPAP is a modality used for babies with both central apneas and mild/moderate increase work of breathing. CPAP increases the FRC and ultimately recruits collapsed alveoli and improves gas exchange in the lungs. BiPhasic, on the other hand, is a modality used for babies that require more respiratory support than CPAP can provide. In BiPhasic mode, respiratory rate (RR), inspiratory time (Ti), and peak inspiratory pressures (PIP) are set and not synchronized with the patients breathing efforts.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment