Assessment of NeuroBOX and NeuroPAP in Infants.
Condition: Pediatric Respiratory Diseases; Bronchiolitis; Infant Respiratory Distress Syndrome
MeSH terms: Bronchiolitis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      Non-invasive ventilation (NIV, delivered via a mask or cannulas) permits to reduce the need
      for tracheal intubation in infants who needs a ventilatory support. NIV can be delivered with
      nasal CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive
      pressure ventilation). The synchronization of the respiratory support according to the
      patient's demand is very difficult to obtain in infants with the conventional ventilatory
      modes. In all these ventilatory modes, the end-expiratory pressure (PEEP) is fixed and set by
      the clinician. However, since infants are prone to alveolar collapse and must compensate for
      a non-compliant chest wall, an active and ongoing management of PEEP is very important to
      prevent the lung de-recruitment.

      A new respiratory support system (NeuroPAP) has been developed to address these issues of
      synchronization and control of PEEP. This new system uses diaphragmatic tonic activity (Edi)
      that reflects the patient's efforts to increase lung recruitment and therefore it
      continuously controls the delivery of assist continuously both during inspiration (like NAVA)
      and during expiration, allowing a unique neural control of PEEP.

      A new device, the NeuroBOX, permits to deliver NIV with NeuroPAP, CPAP, or NIPPV, and also to
      serve as a cardio-respiratory monitor, tracking and displaying cardiac and respiratory
      signals, trends, and cardio-vascular events.

      The two main objectives of this study are: 1- To evaluate the clinical impact of NeuroPAP in
      infants with high tonic Edi; 2- To characterize the cardio-respiratory pattern and its
      relationship with cerebral perfusion of infants with noninvasive support, using the
      monitoring capacity of the NeuroBOX.

      The investigators expect that NeuroPAP will permit to improve the efficiency of NIV in
      infants, through the better synchronization and the personalization of the expiratory
      pressure level in response to the patient needs.

      This study will be conducted in two subgroups of patients at high risk of elevated tonic Edi
      and of cardio-respiratory events: a subgroup of premature infants and a subgroup of infants
      with bronchiolitis.
    


Intervention name(s): NeuroPAP ventilation (2h) and NeuroBox monitoring (23h); NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
Intervention type(s): Device; Device
Intervention description(s): Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted; Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective single center crossover study with two different arms, one conducted in the Neonatal Intensive Care Unit and the other in the Pediatric Intensive Care Unit.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intensive Care; mechanical ventilation; noninvasive ventilation