Clinical trial NCT03650478: Assessment of NeuroBOX and NeuroPAP in Infants.
Official title: Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Respiratory Diseases
Bronchiolitis
Infant Respiratory Distress Syndrome
Keywords: Intensive Care
mechanical ventilation
noninvasive ventilation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Maquet Critical Care
First posted: 2018-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

For premature infants group:

* Preterm infants born at a gestational age (GA) between 25 weeks (+0/7 days) and 34 weeks inclusively
* With post-birth age : \> 2 days (for birth GA \>28 weeks) or \> 6 days (GA \<28weeks) and \< 4 months
* on non-invasive support, including CPAP, NIPPV, or NAVA, with settings in the following range : Maximal inspiratory pressure (total, including PEEP) ≤ 20 cmH2O, and PEEP between 4 and 9 cmH2O, and FiO2 \< 50%

For bronchiolitis group:

* Infants with a weight \< 5kg and a clinical diagnosis of bronchiolitis.
* on non-invasive support, including CPAP, NIPPV, or NAVA with settings in the range: Delivered inspiratory pressure (total, including PEEP) ≤ 20 cmH2O and PEEP: 5-9 cmH2O, and FiO2 \<60 %
* With persisting respiratory failure: presence of at least one of the following criteria:

  * Respiratory rate \> 50 /min
  * Symptoms of respiratory distress: mWCAS \> 3
  * FiO2 \> 30% -
  * Inspiratory Edi consistently \> 15 µV

Exclusion Criteria: for both premature infants and bronchiolitis groups

* Suspected or proven pneumothorax;
* Patient on high-flow nasal cannula or on NAVA;
* Contra-indications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions);
* Hemodynamic instability requiring inotropes;
* Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 \> 50% to achieve a SpO2\>90%, or PaCO2 \> 75 mmHg on the last blood gas;
* Patient for whom a limitation of life support treatments is discussed or decided;
* Refusal by the treating physician;
* Refusal by the parents or legal guardians.

Primary outcomes:
measure: Changes in indices of respiratory unloading
timeFrame: Last 5-minute period of each condition phase
measure: Incidence of cardio-respiratory events
timeFrame: over 25 hours (Entire recordings)
Secondary outcomes:
measure: Change in End expiratory lung volume (EELV) level
timeFrame: 5-minute period before and after the change of ventilatory mode
measure: Change in Indices of cerebral oxygenation and perfusion
timeFrame: Last 5-minute period of each condition phase
measure: Change in comfort level in preterm infants
timeFrame: Last 5-minute period of each condition phase
measure: Change in comfort level in infants with bronchiolitis.
timeFrame: Last 5-minute period of each condition phase
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St. Justine's Hospital
state: Quebec
Study officials:
affiliation: CHU Sainte Justine, Université de Montréal
name: Guillaume Emeriaud, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: