Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants
Condition: Premature Birth; Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth
Study type: Interventional

Summary: 
      Strategies to prevent lung injury, facilitate lung development, and to support the preterm
      infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the
      gold standard in non-invasive breathing support in preterm infants with a positive pressure
      that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted
      ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical
      activity from the diaphragm to trigger the ventilator and synchronize with the breathing
      cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the
      respiratory rate, inspiratory time and peak pressure. This method has the potential to
      improve the positive pressure transmission to the infant's lower airways, accurate
      synchronization with the breathing pattern and be a comfortable breathing support system for
      the preterm infant.

      The investigators will compare the effect on breathing effort in preterm infants during
      continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist
      measured by electrical activity in the diaphragm, respiratory vital signs, systematic
      clinical scoring of breathing effort and comfort, and parent reported outcomes.
    

Detailed description: 
      This is a randomized cross-over study with AB/BA sequences. The infants will receive both
      interventions in 4 hours intervals, a 30 minutes period to change the breathing support and a
      30 minutes wash out period between interventions. Initially positive end expiratory pressure
      are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team
      for both interventions. The neurally adjusted level will be set to obtain average Edi peak <
      15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA)
      will be individualized according to clinical parameters in each preterm infant.

      Modification approved by ethical committee REK 2021, 6th of August:

      After two hours in each intervention, the nurse responsible for the infant will perform the
      clinical scoring. In addition it will be investigated if there is a difference in respiratory
      vital signs during skin to skin care and in the incubator. During each intervention period,
      the preterm infants are placed on the parent's chest skin to skin for at least one hour.

      A modified version of the scoring tool will be used, i.e. without the item of nasal flaring
      and expiratory grunting. The headgear for CPAP and NIV NAVA covers parts of the nose and
      makes nasal flaring difficult to observe.
    

Intervention name(s): CPAP; NIV NAVA
Intervention type(s): Device; Device
Intervention description(s): Continuous positive airway pressure; Non-invasive neurally adjusted ventilatory assist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infants, preterm; Respiration, Artificial; Diaphragm; Intensive Care Units, Neonatal; Continuous Positive Airway Pressure; Non invasive neurally adjusted ventilator assist