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Assessment of NeuroBOX and NeuroPAP in Infants. (NeuroPap2)

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ClinicalTrials.gov Identifier: NCT03650478
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Maquet Critical Care
Information provided by (Responsible Party):
Dr Guillaume Emeriaud, St. Justine's Hospital

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.


Condition or disease Intervention/treatment Phase
Pediatric Respiratory Diseases Bronchiolitis Infant Respiratory Distress Syndrome Device: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h) Device: NeuroPAP ventilation (4h) and NeuroBox monitoring (25h) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Experimental: Premature infants group
NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)
Device: NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
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

Experimental: Bronchiolitis group
NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
Device: NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)
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




Primary Outcome Measures :
  1. Changes in indices of respiratory unloading [ Time Frame: Last 5-minute period of each condition phase ]
    The inspiratory and tonic Edi will be extracted from the NeuroBOX during each phase. The mWCAS, a clinical scale of work of breathing, will be blindly collected during each ventilatory condition in the bronchiolitis patients.

  2. Incidence of cardio-respiratory events [ Time Frame: over 25 hours (Entire recordings) ]
    the number of apneas >20s, with and without desaturations and with/without bradycardia, and the number of bradycardia will be extracted from the NeuroBOX. This is a descriptive analysis, not a comparative analysis.


Secondary Outcome Measures :
  1. Change in End expiratory lung volume (EELV) level [ Time Frame: 5-minute period before and after the change of ventilatory mode ]
    change in EELV will be assessed using the 3D video-derived volumetry, comparing the mean EELV level in the 5 minutes before and after the change of ventilatory mode (from conventional NIPPV to NeuroPAP and the reverse).

  2. Change in Indices of cerebral oxygenation and perfusion [ Time Frame: Last 5-minute period of each condition phase ]
    FDNIRS-DCS technology will be used to measure the indices of cerebral oxygen metabolism, blood flow and tissue hemoglobin saturation

  3. Change in comfort level in preterm infants [ Time Frame: Last 5-minute period of each condition phase ]
    assessed by the bedside nurse in charge using the Pain/Agitation component of the validated scale N-PASS (neonatal pain, agitation, and sedation scale). The Pain/Agitation component varies from 0 to 10, and a lower score reflects a better comfort.

  4. Change in comfort level in infants with bronchiolitis. [ Time Frame: Last 5-minute period of each condition phase ]
    assessed by the bedside nurse in charge using the validated scale FLACC (Face, Legs, Activity, Cry, Consolability scale). The FLACC score varies from 0 to 10 and a lower score reflects a better comfort.



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650478


Contacts
Contact: Guillaume Emeriaud, MD PhD +15143454931 ext 4788 guillaume.emeriaud@umontreal.ca

Locations
Canada, Quebec
St. Justine's Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Maquet Critical Care
Investigators
Principal Investigator: Guillaume Emeriaud, MD PhD CHU Sainte Justine, Université de Montréal

Responsible Party: Dr Guillaume Emeriaud, Principal Investigator, Intensivist, Clinical Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03650478     History of Changes
Other Study ID Numbers: CHUSJ-1841
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Guillaume Emeriaud, St. Justine's Hospital:
Intensive Care
mechanical ventilation
noninvasive ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchiolitis
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections