A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is
      preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal
      continuous positive airway pressure (CPAP) or nasal intermittent positive pressure
      ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed
      end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain
      in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed.
      Considering that preterm infants are more likely to develop atelectasis, an active and
      ongoing management of the PEEP is very important to prevent de-recruitment.

      A new respiratory support system (NeuroPAP) was developed to address these issues
      (synchronization problems and control the PEEP). It uses the electrical activity of the
      diaphragm (EDI) to control the ventilator assist continuously, both during inspiration
      (principle of NAVA mode) and also during expiration (based on tonic Edi level).
    

Detailed description: 
      The mode NeuroPAP will work with the continuous Edi-level and deliver pressures according to
      the Edi-signal x set NeuroPAP-level, over the whole breath (inspiration and expiration). The
      NeuroPAP will work between two pressure levels set by the user and named higher Pressure
      limit (Plimit) and minimum Pressure (Pmin).

      A safety upper pressure limit (UPL) will also be set. A backup ventilation will be possible.

      A specific gastric tube equipped with an array of microelectrodes (Edi catheter, Maquet,
      Solna, Sweden) will be installed after inclusion, by the same oral or nasal route as the tube
      previously in place. Patients will then be ventilated in the 5 aforementioned conditions:

        -  On conventional NIPPV device on clinical settings for a 30 minute period. The
           investigators will note the mean airway pressure being delivered with the clinical
           settings and the resulting peak Edi, as well as neural respiratory rate, tonic Edi,
           Fraction of inspired oxygen (FiO2), and Oxygen saturation by pulse oximetry (SpO2).

        -  With NeuroPAP without modification of Pmin (=peep). The exchange of the nasal interface
           may be necessary, depending on the original interface. FiO2 will initially be the same
           as previously set in conventional NIPPV. The Pmin will initially be set at the level of
           PEEP used during conventional NIPPV. A titration maneuver will be conducted to identify
           the optimal NeuroPAP level. The infant will be ventilated for one hour. Clinical
           adjustments in pressures and FiO2 are permitted. Safety termination will be established.

        -  NeuroPAP with adjusted Pmin: the Pmin in NeuroPAP will be reduced by 2 cm H2O, with the
           same NeuroPAP level. The patients will be ventilated for one hour.

        -  CPAP delivery with NeuroPAP device: the device will be switched to CPAP mode, for a 15
           minute period

        -  A second 30 minutes period of the conventional NIPPV will be conducted.
    

Intervention name(s): NeuroBox to deliver the NeuroPAP
Intervention type(s): Device
Intervention description(s): The patients will be studied during the following conditions:
On conventional NIPPV device with the clinically prescribed settings (30 min)
With NeuroPAP and no change of Pmin (=peep) (60 min)
With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min)
During CPAP delivered with NeuroPAP device (15 min)
Again with original NIPPV device and settings for 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; NIV; NIPPV; Edi