- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03650478
Assessment of NeuroBOX and NeuroPAP in Infants. (NeuroPap2)
Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume Emeriaud, MD PhD
- Phone Number: 4788 +15143454931
- Email: guillaume.emeriaud@umontreal.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C5
- St. Justine's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Premature infants group
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 (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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Last 5-minute period of each condition phase
|
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.
|
over 25 hours (Entire recordings)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
5-minute period before and after the change of ventilatory mode
|
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
|
Last 5-minute period of each condition phase
|
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.
|
Last 5-minute period of each condition phase
|
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.
|
Last 5-minute period of each condition phase
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUSJ-1841
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedBronchiolitis Obliterans | Graft vs Host Disease | Constrictive Bronchiolitis | Bronchiolitis, Exudative | Bronchiolitis, ProliferativeUnited States
-
Hillel Yaffe Medical CenterCompletedReflexology | Bronchiolitis; ChemicalIsrael
-
Guy's and St Thomas' NHS Foundation TrustCompletedAcute Viral BronchiolitisUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisCompletedAcute Viral BronchiolitisFrance
-
Ministry of Health, SpainCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedBronchiolitis Obliterans | Graft Versus Host Disease | Graft-Versus-Host Disease | Constructive Bronchiolitis | Bronchiolitis, Exudative | Bronchiolitis, ProliferativeUnited States
-
Hospices Civils de LyonRecruiting
-
Assistance Publique - Hôpitaux de ParisCompletedSevere Viral BronchiolitisFrance
-
University Hospital, Basel, SwitzerlandRecruitingBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Switzerland, Saudi Arabia
-
Groupe Hospitalier du HavreCompletedAcute Viral BronchiolitisFrance
Clinical Trials on NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)
-
Hospices Civils de LyonCompletedAnesthesia | Peroperative ComplicationFrance
-
Centre Hospitalier Universitaire DijonCompletedObesity | General Anesthetic | Positive Expiratory PressureFrance
-
University Hospital OstravaRecruitingARDS | Lung Injury, Ventilator InducedCzechia
-
Beth Israel Deaconess Medical CenterBreas Medical S.A.R.L.Withdrawn
-
Centre Chirurgical Marie LannelongueUnknown
-
Shanghai Zhongshan HospitalUnknownSalvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic SurgeryNitric Oxide | Hypoxemia | Aortic SurgeryChina